Do 0–10 Numeric Rating Scores Translate into Clinically Meaningful Pain Measures for Children? Validity of Simplified Versus Standard Self-Report Measures of Pain Intensity in Preschool-Aged Children Undergoing Venipuncture. Cyproheptadine for the treatment of functional abdominal pain in childhood: a double-blinded randomized placebo-controlled trial. Systematic review of effectiveness of universal self-regulation-based interventions and their effects on distal health and social outcomes in children and adolescents: review protocol Pain in 4- to 6-year-old children receiving intramuscular injections: a comparison of the Faces Pain Scale with other self-report and behavioral measures. “Effectiveness of interventions in reducing pain and maintaining physical activity in children and adolescents with calcaneal apophysitis (Sever’s disease): a systematic review” Developmental data supporting simplification of self-report pain scales for preschool-age children. Preliminary validation of the Defense and Veterans Pain Rating Scale (DVPRS) in a military population. Obesity in children. Part 2: Prevention and management Efficacy and tolerability of lithium in treating acute mania in youth with bipolar disorder: protocol for a systematic review The faces pain scale for the self-assessment of the severity of pain experienced by children: Development, initial validation, and preliminary investigation for ratio scale properties Longitudinal Changes in Psychosocial Factors and Their Association With Knee Pain and Function After Anterior Cruciate Ligament Reconstruction Implementation and preliminary effectiveness of a real‐time pain management smartphone app for adolescents with cancer: A multicenter pilot clinical study The psychometric properties of the MASC in a pediatric psychiatric sample. Reliability of the visual analog scale in children with acute pain in the emergency department Validation of Self-Report Pain Scales in Children Relationships between cognitive behavioral techniques, temperament, observed distress, and pain reports in children and adolescents during lumbar puncture. Criterion and Convergent Validity for 4 Measures of Pain in a Pediatric Sickle Cell Disease Population Promising insights into the health related quality of life for children with severe obesity Development of a research-based standard for assessment, intervention, and evaluation of pain after neonatal and pediatric cardiac surgery. Pain-QuILT: Assessing Clinical Feasibility of a Web-based Tool for the Visual Self-Report of Pain in an Interdisciplinary Pediatric Chronic Pain Clinic Evidence‐based management of pain after laparoscopic cholecystectomy: a PROSPECT review update Children's ratings of the intensity and unpleasantness of post-operative pain using facial expression scales. Effectiveness of workplace interventions in rehabilitating musculoskeletal disorders and preventing its consequences among workers with physical and sedentary employment: systematic review protocol Assessment of study quality for systematic reviews: a comparison of the Cochrane Collaboration Risk of Bias Tool and the Effective Public Health Practice Project Quality Assessment Tool: methodological research. The effectiveness of music on pain among preterm infants in the neonatal intensive care unit: a systematic review Analgesic efficacy and safety of single-dose intramuscular ketorolac for postoperative pain management in children following tonsillectomy Diagnosis and Treatment of Low Back Pain: A Joint Clinical Practice Guideline from the American College of Physicians and the American Pain Society A new analogue scale for assessing children's pain: an initial validation study Randomized controlled trial of an Internet-delivered family cognitive–behavioral therapy intervention for children and adolescents with chronic pain Effectiveness of Virtual Reality for Pediatric Pain Distraction during IV Placement Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations
BACKGROUND : Self-reported pain scores are used widely in clinical and research setting s , yet little is known about their interpretability in children . In this prospect i ve , observational study we evaluated the relationship between 0 to 10 numerical rating scale ( NRS ) pain scores and other self-reported , clinical ly meaningful outcomes , including perceived need for medicine ( PNM ) , pain relief ( PR ) , and perceived satisfaction ( PS ) with treatment in children postoperatively . METHODS : This study included children ages 7 to 16 years undergoing surgery associated with postoperative pain . One to 4 observations were recorded in each child within the first 24 hours postoperatively . At each assessment , children rated their pain with the NRS , stated their PNM , and rated their satisfaction with  pain management .  Assessment s were repeated within 1 to 2 hours , and children additionally rated their PR as the same , better , or worse in comparison with the earlier assessment . Receiver operator characteristic curves were developed to examine potential NRS cut-points for PNM and PS , and the minimum clinical ly significant difference ( MCSD ) in pain score associated with PR was calculated . RESULTS : Three hundred ninety-seven observations ( including 189 pairs ) were recorded in 113 children .  NRS scores associated with PNM were significantly higher than “ no need ” ( median 6 vs. 3 ; P < 0.001 ) . NRS scores > 4 had good sensitivity ( 0.81 ) and specificity ( 0.70 ) to discriminate PNM , but with a large number of false positives and negatives ( e.g. , 42 % of children with scores > 4 did not need analgesia ) . The MCSD in NRS scores was −1 ( 95 % confidence interval [ CI ] −0.5 to 1 ) or + 1 ( CI 0.5 to 2.7 ) in relation to feel “ a little better ” or “ worse , ” respectively ( P < 0.001 vs. the same ) . NRS scores > 6 had a sensitivity of 0.82 and specificity of 0.76 in discriminating dissatisfaction with treatment , yet 46 % and 24 % of children with scores > 6 , respectively , were somewhat to very satisfied with their analgesia . CONCLUSIONS : This study provides important information regarding the clinical interpretation of NRS pain scores in children . Data further support the NRS as a valid measure of pain intensity in relation to the child 's PNM , PR , and PS in the acute postoperative setting . However , the variability in scores in relation to other clinical ly meaningful outcomes suggests that application of cut-points for individual treatment decisions is inappropriate There are inadequate age-specific data to support the use of current self-report pain scales in 3- and 4-year-old children . Most preschool-aged children also lack the necessary cognitive development to use st and ard scales . We aim ed to evaluate the validity and feasibility of 2 novel simplified scales ( Simplified Faces Pain Scale , S-FPS ; Simplified Concrete Ordinal Scale , S-COS ) for preschool-aged children . These simplified scales used a 2-step self-report method : children were first asked whether they have pain ( yes/no ) ; only if yes , then pain intensity was self-reported using a 3-point scale with visual aids signifying mild/moderate/severe . We recruited 180 3- to 6-year-old children undergoing routine blood collection . Each child was r and omly assigned 2 of 3 scales-S-FPS , S-COS , Faces Pain Scale-Revised (FPS-R)-to self-report pain before venipuncture , immediately after , and 5 minutes later , using both scales at each time-point . Pain was also assessed using observation ( Face Legs Activity Cry Consolability ) at each time point . The ability to discriminate pain from no pain was improved with S-FPS and S-COS , compared with the FPS-R , among 4-year-olds , but not 3-year-olds . Correlation with Face Legs Activity Cry Consolability was moderate to strong and cooperation rates were similar for all self-report scales . The simplified scales can improve and simplify pain assessment for 4-year-olds . Quantitative pain rating remains challenging for 3-year-olds . PERSPECTIVE This study evaluated 2 novel simplified pain assessment tools for preschool-aged children undergoing blood sampling . These scales demonstrated good validity and feasibility compared with the FPS-R , suggesting these simplified pain scales may have a role in clinical practice for children as young as 4 years AIM The management of functional abdominal pain ( FAP ) in children and adolescents is challenging for health care professionals , and there are only limited or inconclusive studies of pharmacologic or behavioral therapy in childhood FAP . The objective of this r and omized placebo-controlled clinical trial was to determine the potential efficacy and safety of cyproheptadine in the treatment of pediatric FAP . METHODS Between January 2006 and March 2007 , 29 clinical ly referred children and adolescents with FAP ( aged 4.5 to 12 years ) completed a 2-week , double-blinded r and omized placebo-controlled trial of cyprohetadine . Primary outcome measure was the self-reported change of frequency and duration of abdominal pain by using a 6-point scale , and the parents ' impression or assessment of the children 's improvement . RESULTS By week 1 and 2 of the intervention , the intensity and frequency of abdominal pain among the patients treated with cyproheptadine , were rated as complete resolved and very much improved or improved for 3 ( 20 % ) , 10 ( 66.6 % ) , respectively . However , in the placebo-receiver children , these scales had no change in 7 ( 50 % ) , rated as improved or very much improved in 5 ( 35.7 % ) , and become worse in 2 ( 14.3 % ) . The patients ' self-reported and the parents ' impression in the cyproheptadine group were significantly better than it in the placebo group ( P=0.003 ) . CONCLUSION Among children with functional abdominal pain , cyproheptadine is enough effective to improve the intensity and frequency of abdominal pain in a short-term period Background Growing evidence suggests that childhood and adolescence self-regulation contributes to multiple health , educational and social outcomes . Considering the potential impact of self-regulation skills on improved life chances in conjunction with evidence suggesting that self-regulation can be modified by interventions , there is a need to identify interventions which are most effective in improving childhood and adolescence self-regulation . The present systematic review was design ed to determine the effectiveness of universal interventions focused on enhancing the  self-regulation of children and adolescents . As secondary outcomes , we will also examine the effectiveness of such interventions on distal health and social outcomes . Methods Eligible studies include r and omised controlled trials ( including cluster r and omised trials ) reporting on universal interventions design ed to improve self-regulation in childhood and adolescence ( age 0–19 years ) . The following data bases will be search ed for peer- review ed publications using an iterative search strategy : Medline , PsycINFO , EMBASE , ERIC , CINAHL Plus , British Education Index , Child Development & Adolescent Studies and CENTRAL without applying language or date filters . Additionally , reference lists and citations of included studies will be search ed for eligible studies . A 10 % proportion of the total titles and abstract s will be r and omly selected and screened independently by two review ers ( AP and DH ) . Results will be compared to ensure less than 5 % discrepancy , followed by screening of all results by one review er ( AP ) . Full-text review and data collection will be independently performed by two review ers . Any discrepancies will be solved by mutual discussion , and if unresolved , a third review er ( RV ) will be consulted . Meta- analysis will be conducted to quantify trial effects , if the data is sufficiently homogenous to allow quantitative synthesis . Otherwise , results will be described narratively . Discussion The evidence derived from the systematic review will strengthen the evidence base to inform planning of effective interventions targeting self-regulation skills in childhood and adolescence . This will benefit policy makers , academicians , research ers , health professionals , and also , young people who will benefit from policy and interventions informed by this review . Systematic review registration CRD42016047661 OBJECTIVE The main objective was to compare the utility of the Faces Pain Scale  ( Bieri et al. , 1990 ) with three alternative self-report measures of pain intensity in children , as well as with pain ratings based on observations of the child 's behavior . DESIGN Fifty children used 4 self-report scales to rate the severity of needle pain from routine immunization . Using videotapes , the child 's pain-related behavior was coded in detailed fashion , and a subset of the sample were also rated globally by 60 registered pediatric nurses . MAIN OUTCOME MEASURES  Faces Pain Scale ; Poker Chip Tool ; Visual Analogue Toy ; Verbal Rating Scale ;  behavioral checklist ( scoring observable facial , motor , verbal and vocal reactions ) . RESULTS AND CONCLUSIONS The  Faces Pain Scale  was simple to use , readily understood by the children , and showed a realistic distribution of scores with respect to the type of pain being measured . With the exception of verbal reactions ( which were not meaningfully related to self-report ) , observer ratings based on detailed coding of the child 's behavior correlated only poorly to moderately well with self-report scores ( r = .39 to r = .58 ) . Similarly , although confident in their judgments , the nurses ' ratings showed only moderate agreement with those of the children . In estimating the child 's pain , all observers appeared to appropriately weigh changes in the child 's facial behavior , which showed evidence of being the most sensitive behavioral index to the intensity of short sharp ( needle ) pain in 4 to 6 years olds Background Calcaneal apophysitis , also commonly known as sever ’s disease , is a condition seen in children usually aged between 8–15 years . Conservative therapies , such as taping , heel lifts and orthotic intervention are accepted management practice s for calcaneal apophysitis , though there is very little high quality research examining the efficacy of such treatment modalities . Previous narrative literature review s and opinion pieces provide some evidence for the use of heel raises or orthoses . The aim of this manuscript was to complete a systemic review on the treatment options for calcaneal apophysitis as measured by pain reduction and maintenance of physical activity . Methods A search strategy completed by two review ers examined nine data bases from inception to May 2012 . Search terms included heel pain , children , adolescent , calcaneal apophysitis , sever ’s disease , treatment , and management ( full text publications , human studies ) . Systematic review s , r and omised control trials , case series , and case studies were included . The reference lists of the selected articles were also examined . The methodology , quality and risk of bias was examined and assessed using the PEDro scale . Results Nine articles were retrieved including three clinical trials involving r and omisation , two case series , two retrospective case review s , and two case reports . Effect size calculations and a meta analysis were unable to be completed due to the limited data reported within the literature . Numerous treatment options were reported throughout the literature , though few were examined against a control or alternate treatment option in well- design ed trials . The limited evidence indicated that orthoses provided greater short-term pain relief than heel raises . Health practitioners should view these results with caution , as there were apparent method ological problems with the employed study design and limited follow-up of participants . Conclusion There is limited evidence to support the use of heel raises and orthoses for children who have heel pain related to calcaneal apophysitis . Further research is needed to generate higher quality evidence with larger sample sizes , and vali date d measures of pain and function to establish effective treatment approaches for children with calcaneal apophysitis UNLABELLED Cl aims regarding the ability of preschool-age children to provide accurate self-reports using st and ard pain scales are not well supported by age-specific evidence . Responses of children younger than 5 years are often idiosyncratic and subject to biases . Simplifying the task of self-report of pain would make it more developmentally appropriate for 3- to 5-year-olds . A binary question is asked : " Does it hurt ? " or an equivalent . If yes , a simplified scale is presented , comprising 3 categories representing low , medium , and high pain severity . Children aged 3 to 5 years ( N = 184 ) were recruited from preschools and day care centers . Following parental consent and child assent , children were r and omly assigned to use either the  Faces Pain Scale-Revised or a 3-face scale preceded by a yes-no question to rate pain in 9 picture stories from the Charleston Pediatric Pain Pictures portraying no pain , moderate pain , and severe pain . The  simplified pain rating task  made no difference for 5-year-olds , whose mean scores were nearly identical using the 2 approaches . However , discrimination of the 3 levels of Charleston Pediatric Pain Pictures items was significantly better in 3- and 4-year-olds with the simplified task than with the  Faces Pain Scale-Revised .  Simplifying the task improved preschool-age children 's ability to estimate pain intensity . PERSPECTIVE St and ard self-report pain scales with 6 faces are confusing for many 3- and 4-year-olds . In basic preparatory research for future development of a preschool self-report pain scale , we simplified the task . This simplification made no difference for 5-year-olds but improved the performance of 3- and 4-year-olds BACKGROUND The Army Surgeon General released the Pain Management Task Force final report in May 2010 . Among military providers , concerns were raised that the st and ard numeric rating scale ( NRS ) for pain was inconsistently administered and of question able clinical value . In response , the Defense and Veterans Pain Rating Scale ( DVPRS ) was developed . METHODS The instrument design integrates pain rating scale features to improve interpretability of incremental pain intensity levels , and to improve communication and documentation across all transitions of care . A convenience sample of 350 inpatient and outpatient active duty or retired military service members participated in the study at Walter Reed Army Medical Center . Participants completed the five-item DVPRS-one pain intensity NRS with and without word descriptors presented in r and om order and four supplemental items measuring general activity , sleep , mood , and  level of stress and the Brief Pain Inventory seven interference items . Using systematic sampling , a r and om sample was selected for a word descriptor validation procedure matching word phases to corresponding pain intensity on the NRS . RESULTS Parallel forms reliability and concurrent validity testing demonstrated a robust correlation . When the DVPRS was presented with the word descriptors first , the correlation between the two ratings was slightly higher , r = 0.929 ( N = 171 ; P < 0.001 ) , than ordering first without the descriptors , r = 0.882 ( N = 177 ; P < 0.001 ) . Intraclass correlation coefficient was 0.943 showing excellent alignment of word descriptors by respondents ( N = 42 ) , matching them correctly with pain level . CONCLUSIONS The DVPRS tool demonstrated acceptable psychometric properties in a military population # # # # Summary points In the first part of this article we described how obesity in children is measured , its prevalence , whether children should be screened , and the risk factors for and consequences of obesity.1 In this part we review the current evidence on the prevention and management of childhood obesity . # # # # Sources and selection criteria This review draws on the Foresight report , guidance from the National Institute for Health and Clinical Excellence and the Australian National Health Medical Research Council , and Cochrane review . In April 2008 we search ed the Cochrane Library data base of review s and the Centre for Review s and Dissemination data bases using the search term “ obesity ” . We also conducted a Medline search ( ( Child$ or paediatric or pediatric or adolescent ) and ( Obes$ or overweight ) ) limited to 1 January 2005 to 6 May 2008 and “ review articles ” ; this identified 1105 articles . We read the abstract s of these articles and retrieved relevant papers . We also used articles from our own bibliographies collected over the past 10 years . The evidence to support the measurement , prevention , and management of obesity in children is still relatively weak , with few r and omised controlled trials or systematic review s. The strength of evidence is developing and the up date d Cochrane review that will be published in 2009 Background Epidemiological , clinical , and high-risk studies have provided evidence that the peak period for onset of diagnosable episodes of mania and hypomania starts in mid-to-late adolescence . Moreover , clinical ly significant manic symptoms may occur even earlier , especially in children at familial risk . Lithium is the gold st and ard treatment for acute mania in adults , yet to our knowledge , there is no published systematic review assessing lithium treatment of mania in children or adolescents . This is a major gap in knowledge needed to inform clinical practice . Aim As a working group within the ISBD Task Force on Lithium Treatment ( http://www.isbd.org/active-task-forces ) , our aim is to complete a systematic review of the efficacy , tolerability , and acceptability of lithium compared with placebo and other active drugs in treating mania in children and adolescents diagnosed with bipolar disorder . Methods We will include double- or single-blind r and omized controlled trials in patients aged less than 18 years . No restrictions will be made by study publication date or language . Several electronic data bases will be search ed along with secondary sources such as bibliographies and trial registry websites for published and unpublished studies . Response rates to lithium compared with placebo or other active drugs will be the primary efficacy outcome . Primary tolerability and acceptability outcomes will be rates of serious adverse events and dropouts , respectively . Secondary outcomes will include rates of remission , severity of manic symptoms at different time points , and incidence of specific adverse events . Discussion Findings from this systematic review are critically needed to inform clinical practice . We should not generalize findings from adult studies , as children and adolescents are undergoing accelerated physiological and brain development . Therefore , efficacy , tolerability , and acceptability of lithium treatment of acute mania in children compared to adults may be very different . This systematic review has been registered in PROSPERO ( CRD42017055675 ) & NA ; Altogether 553 children ( 195 first grade rs , mean age 6.8 years , and 358 third grade rs , mean age 8.7 years ) participated in the development of a self‐report measure to assess the intensity of children 's pain .  The first step was the derivation , from children 's drawings of facial expressions of pain , of 5 sets of 7 schematic faces depicting changes in severity of expressed pain from no pain to the most pain possible . With the set of faces that achieved the highest agreement in pain ordering , additional studies were conducted to determine whether the set had the properties of a scale . In one study , children rank‐ordered the faces on 2 occasions , separated by 1 week . All 7 faces were correctly ranked by 64 % ( retest 1 week later , 61 % ) of grade 1 children and by 86 % ( retest 89 % ) of grade 3 children . In a second study , the faces were presented in all possible paired combinations . All 7 faces were correctly placed by 62 % ( retest 86 % ) of the younger and by 75 % ( retest 71 % ) of the older subjects . A third study asked children to place faces along scale : a procedure allowing a check on the e quality of intervals . The fourth study checked on whether pain was acting as an underlying construct for ordering the faces in memory . We asked whether children perceived the set as a scale by asking if memory for an ordered set of faces was more accurate than for a r and om set . The final study checked , with 6‐year‐old children , the test‐retest reliability of ratings for recalled experiences of pain . Overall , the faces pain scale incorporates conventions used by children , has achieved strong agreement in the rank ordering of pain , has indications that the intervals are close to equal , and is treated by children as a scale . The test‐retest data suggest that it may prove to be a reliable index over time of self‐reported pain Background Evidence in the musculoskeletal rehabilitation literature suggests that psychosocial factors can influence pain levels and functional outcome . Objective The purpose of this study was to examine changes in select psychosocial factors and their association with knee pain and function over 12 weeks after anterior cruciate ligament ( ACL ) reconstruction . Design This was a prospect i ve , longitudinal , observational study . Methods Patients with ACL reconstruction completed self-report question naires for average knee pain intensity ( numeric rating scale [ NRS ] ) , knee function ( International Knee Documentation Committee Subjective Knee Form [ IKDC-SKF ] ) , and psychosocial factors ( pain catastrophizing [ Pain Catastrophizing Scale ] , fear of movement or reinjury [ shortened version of the Tampa Scale for Kinesiophobia ( TSK-11 ) ] , and self-efficacy for rehabilitation tasks [ modified Self-Efficacy for Rehabilitation Outcome Scale ( SER ) ] ) . Data were collected at 4 time points after surgery ( baseline and 4 , 8 , and 12 weeks ) . Repeated- measures analyses of variance determined changes in question naire scores across time . Hierarchical linear regression models were used to examine the association of psychosocial factors with knee pain and function . Results Seventy-seven participants completed the study . All question naire scores changed across 12 weeks . Baseline psychosocial factors did not predict the 12-week NRS or IKDC-SKF score . The 12-week change in modified SER score predicted the 12-week change in NRS score ( r2=.061 ) , and the 12-week change in modified SER and TSK-11 scores predicted the 12-week change in IKDC-SKF score ( r2=.120 ) . Limitations The psychometric properties of the psychosocial factor question naires are unknown in people with ACL reconstruction . The study focused on short-term outcomes using only self-report measures . Conclusions Psychosocial factors are potentially modifiable early after ACL reconstruction . Baseline psychosocial factor levels did not predict knee pain or function 12 weeks postoperatively . Interventions that increase self-efficacy for rehabilitation tasks or decrease fear of movement or reinjury may have potential to improve short-term outcomes for knee pain and function BACKGROUND Pain in adolescents with cancer ( 12 - 18 years ) is common and negatively impacts health-related quality of life ( HRQL ) . The Pain Squad+ smartphone app , which provides adolescents with real-time pain self-management support , was developed to address this issue . This study evaluated the implementation of the app to inform a future r and omized controlled trial ( RCT ) and obtain treatment effect estimates for pain intensity , pain interference , HRQL , and self-efficacy . PROCEDURE A one-group baseline/post study design with 40 adolescents recruited from two pediatric tertiary care centers was used . Baseline question naires were completed and adolescents used the app at least twice daily for 28 days , receiving algorithm-informed self-management advice depending on their reported pain . A nurse received alerts in response to sustained pain and contacted adolescents to assist in pain care . Post study question naires were completed . Descriptive analyses , with exploratory inferential testing conducted on health outcome data , were used to address study aims . RESULTS Most ( 40/52 ; 77 % ) eligible adolescents participated . Two participants withdrew participation . Intervention fidelity was impacted by technical difficulties ( occurring for 15 % of participants ) and a prolonged time for nurse contact in the event of sustained pain . Adherence to pain reporting was 68.8 ± 38.1 % . Outcome measure completion rates were high and the intervention was acceptable to participants . Trends in improvements in pain intensity , pain interference , and HRQL were significant , with effect sizes of 0.23 - 0.67 . CONCLUSIONS Implementation of Pain Squad+ is feasible and the app appears to improve pain-related outcomes for adolescents with cancer . A multicenter RCT will be undertaken to examine app effectiveness The goals of this study were twofold : to examine the psychometric properties of the  Multidimensional Anxiety Scale for Children ( MASC ) in a clinical sample of 193 children and adolescents who had received a diagnosis of major depressive or anxiety disorder , and to discriminate between these two groups of patients . Participants had volunteered in r and omized psychopharmacological clinical trials . The MASC four-factor structure was confirmed and its subscales were found to be reliable . The MASC correlated well with other self-report measures of anxiety , and less so with measures of depressive symptoms . The MASC subscales and two MASC items as well as age differentiated between anxious and depressed pediatric patients . If these results are replicated in an independent study , those items could be used by clinicians to discriminate between these two disorders . The MASC is a clinical ly useful measure to discriminate between anxious and depressed pediatric patients . Limitations due to the highly selective sample are noted Summary The repeatability coefficient of the 100‐mm visual analogue scale in children , a measure of test‐retest reliability , is 12 mm when pain did not change . Abstract In children , many psychometric properties of the  visual analogue scale ( VAS )  are known , including the minimum clinical ly significant difference ( 10 mm on a 100‐mm VAS ) . However , its imprecision or reliability is not well known . Thus , in order to determine the reliability of this scale , a prospect i ve cohort study was performed in patients aged 8–17 years presenting to a pediatric emergency department with acute pain . Pain was grade d 4 times using a paper VAS ( 0–100 mm ) : T0 , T3 , T6 , and T⩾36 minutes . After T6 , patients were asked if their pain had changed since T0 minute . The primary analysis was the repeatability coefficient of the VAS , determined according to the Bl and ‐Altman method for measuring agreement using repeated measures in patients reporting that their pain was the same for T0 , T3 , and T6 . In order to appropriately estimate the within‐subject SD , 96 patients were required if we obtained 3 measurements for each patient . A total of 151 patients with a mean age of 12.2 ± 2.5 years were enrolled . Among them , 100 mentioned that their pain was the same for T0 , T3 , and T6 minutes . The repeatability coefficient of the VAS for these children was 12 mm when the pain did not change . This implies that , for a child , all pain intensity measurements within 12 mm should be considered the same pain intensity on a paper VAS . This measure should also be evaluated on other types of VAS BACKGROUND AND OBJECTIVES : The Faces Pain Scale – Revised ( FPS-R ) and Color Analog Scale ( CAS ) are self-report pain scales commonly used in children but insufficiently vali date d in the emergency department setting . Our objectives were to determine the psychometric properties ( convergent validity , discriminative validity , responsivity , and reliability ) of the FPS-R and CAS , and to determine whether degree of validity varied based on age , sex , and ethnicity . METHODS : We conducted a prospect i ve , observational study of English- and Spanish-speaking children ages 4 to 17 years . Children with painful conditions indicated their pain severity on the FPS-R and CAS before and 30 minutes after analgesia . We assessed convergent validity ( Pearson correlations , Bl and -Altman method ) , discriminative validity ( comparing pain scores in children with pain against those without pain ) , responsivity ( comparing pain scores pre- and postanalgesia ) , and reliability ( Pearson correlations , repeatability coefficient ) . RESULTS : Of 620 patients analyzed , mean age was 9.2 ± 3.8 years , 291(46.8 % ) children were girls , 341(55 % ) were Hispanic , and 313(50.5 % ) were in the younger age group ( < 8 years ) . Pearson correlation was 0.85 , with higher correlation in older children and girls . Lower convergent validity was noted in children < 7 years of age . All subgroups based on age , sex , and ethnicity demonstrated discriminative validity and responsivity for both scales . Reliability was acceptable for both the FPS-R and CAS . CONCLUSIONS : The FPS-R and CAS overall demonstrate strong psychometric properties in children ages 4 to 17 years , and between subgroups based on age , sex , and ethnicity . Convergent validity was question able in children < 7 years old A limited number of studies have examined relationships between temperament and children's/adolescents ' responses to painful procedures and have identified several different dimensions of temperament that are related to children 's pain response . The focus of these studies was one-time , acute pain experiences , such as immunization and postoperative pain . In this study , children and adolescents ' responses to a moderately painful procedure , lumbar puncture  , were examined as they related to temperament . Nineteen children and adolescents , ages 4 to 18 years , who were receiving treatment for cancer , were participants in this study . Parents completed one of three age-appropriate temperament question naires at the beginning of the study and prior to the parent and child learning cognitive-behavioral techniques . Behavior during the procedure was videotaped at baseline , and for up to four visits after baseline and coded using the  Observation Scale of Behavioral Distress ( OSBD ) . Pain reports were collected after the procedure using the Oucher pain self-report scale . Improvement in the level of behavioral distress was determined by examining the differences between pre- and post-treatment OSBD scores and self-reported pain ratings . There was a significant improvement in pain reports over the 5-month period , but behavioral distress did not change significantly . At the baseline visit , the temperament dimensions of more positive mood , lower activity , less persistence , and lower distractibility were related to higher pain reports , but not behavioral distress . However , after 5 months , only the dimension of positive mood was significantly correlated with improvement in pain reports . The amount of time parents and children practice d the techniques , their comfort with the techniques and their perceived effectiveness also were correlated with positive mood Objective To evaluate the psychometric properties of 4 measures of acute pain in youth with sickle cell disease ( SCD ) during a medical procedure . Methods Heart rate , child self-report , parent proxy-report , and observable pain behaviors were examined in 48 youth with SCD ages 2 to 17 years . Criterion validity for acute pain was assessed by responsiveness to a st and ardized painful stimulus ( venipuncture ) in a prospect i ve pre-post design . Convergent validity was evaluated through the correlation across measures in reactivity to the stimulus . Results Child self-reported pain , parent proxy-report , and behavioral distress scores increased in response to venipuncture ( concurrent and convergent validity ) . In contrast , heart rate did not reliably change in response to venipuncture . Extent of change in response to venipuncture showed moderate intercorrelation across child and parent pain ratings , and behavioral distress . Preprocedure pain ratings correlated with pain experienced during the procedure . An item analysis of observable pain behaviors suggested differences in the presentation of pain in SCD compared with previous pediatric research . Conclusions Criterion and convergent validity were demonstrated for child-report , parent-report , and observable pain behaviors . These measures seem to tap into distinct , yet overlapping aspects of the pain experience . Assessment of acute procedural pain responses in SCD requires evaluation of preprocedural pain due to the frequent presence of low-level , baseline pain Background Childhood obesity is a growing health concern known to adversely affect quality of life in children and adolescents . The Patient Reported Outcomes Measurement Information System ( PROMIS ) pediatric measures were developed to capture child self-reports across a variety of health conditions experienced by children and adolescents . The purpose of this study is to begin the process of validation of the PROMIS pediatric measures in children and adolescents affected by obesity . Methods The pediatric PROMIS instruments were administered to 138 children and adolescents in a cross-sectional study of patient reported outcomes in children aged 8–17 years with age-adjusted body mass index ( BMI ) greater than the 85th percentile in a design to establish known-group validity . The children completed the  depressive symptoms , anxiety , anger , peer relationships , pain interference , fatigue , upper extremity , and mobility PROMIS domains utilizing a computer interface . PROMIS domains and individual items were administered in r and om order and included a total of 95 items . Patient responses were compared between patients with BMI 85 to < 99th percentile versus ≥ 99th percentile . Results 136 participants were recruited and had all necessary clinical data for analysis . Of the 136 participants , 5 % ended the survey early result ing in missing domain scores at the end of survey administration . In multivariate analysis , patients with BMI ≥ 99th percentile had worse scores for depressive symptoms , anger , fatigue , and mobility ( p < 0.05 ) . Parent-reported exercise was associated with better scores for depressive symptoms , anxiety , and fatigue ( p < 0.05 ) . Conclusions Children and adolescents ranging from overweight to severely obese can complete multiple PROMIS pediatric measures using a computer interface in the outpatient setting . In the 5 % with missing domain scores , the missing scores were consistently found in the domains administered last , suggesting the length of the assessment is important . The differences in domain scores found in this study are consistent with previous reports investigating the quality of life in children and adolescents with obesity . We show that the PROMIS instrument represents a feasible and potentially valuable instrument for the future study of the effect of pediatric obesity on quality of life This analysis of retrospective and prospect i ve data quantified children ( age range 0 - 18 years , total n = 132 ) during their stay in a cardiothoracic intensive care unit and examined pain management and sedation practice s. Data on both factors that could potentially affect pain and its management , and analgesics/sedatives ordered for and administered to subjects were collected from chart review . In the prospect i ve group , pain intensity was measured twice daily using the Wong-Baker FACES Pain Rating Scale . Repeat cardiac surgical procedure subjects reported significantly more pain than nonrepeat subjects on the first postoperative night . Subjects with sternal incisions  reported significantly more pain than subjects with submammary incisions . Not all subjects were premedicated with analgesia for invasive procedures . Significantly greater amounts of analgesia were received by the 0 - 3 year-old subjects . Large amounts of  sedation  were used , especially in children under 3 years of age . The results prompted development of a nursing st and ard to assess and manage pain and sedation in this population Objectives : To evaluate clinical feasibility of the Pain-QuILT ( previously known as the Iconic Pain Assessment Tool ) from the perspective of adolescents with chronic pain and members of their interdisciplinary health team . The Pain-QuILT ( PQ ) , a web-based tool that records the visual self-report of sensory pain in the form of time-stamped records , was directly compared with st and ard interview questions that were transformed to a paper-based tool . Methods : Qualitative , semi-structured interviews were used to refine the PQ . Adolescents with chronic pain aged 12 to 18 years used the PQ and comparator tool ( r and omized order ) to self-report pain before a scheduled clinic appointment , and then took part in a semi-structured interview . The health team used these pain reports ( PQ and comparator ) during patient appointments , and later participated in focus group interviews . Interview audio recordings were transcribed verbatim and underwent a simple line-by-line content analysis to identify key concepts . Results : A total of 17 adolescents and 9 health team members completed the study . All adolescents felt that the PQ was easy to use and underst and . The median time required for completion of the PQ and comparator tool was 3.3 and 3.6 minutes , respectively . Overall , 15/17 ( 88 % ) of adolescents preferred the PQ to self-report their pain versus the comparator . The health team indicated that the PQ was a clinical ly useful tool and identified minor barriers to implementation . Discussion : Consultations with adolescents and their health team indicate that the PQ is a clinical ly feasible tool for eliciting detailed self-report records of the sensory experience of chronic pain Background : Significant pain can be experienced after laparoscopic cholecystectomy . This systematic review aims to formulate PROSPECT ( PROcedure SPECific Postoperative Pain ManagemenT ) recommendations to reduce postoperative pain after laparoscopic cholecystectomy . Methods : R and omised controlled trials published in the English language from January 2006 ( date of last PROSPECT review ) to December 2017 , assessing analgesic , anaesthetic , or operative interventions for laparoscopic cholecystectomy in adults , and reporting pain scores , were retrieved from MEDLINE and Cochrane data bases using PRISMA ( Preferred Reporting Items for Systematic Review s and Meta‐Analyses ) search protocol s. PROSPECT methodology was used , and recommendations were formulated after review and discussion by the PROSPECT group ( an international group of leading pain specialists and surgeons ) . Results : Of 1988 r and omised controlled trials identified , 258 met the inclusion criteria and were included in this review . The studies were of mixed method ological quality , and quantitative analysis was not performed because of heterogeneous study design and how outcomes were reported . Conclusions : We recommend basic analgesic techniques : paracetamol + NSAID or cyclooxygenase‐2 specific inhibitor + surgical site local anaesthetic infiltration . Paracetamol and NSAID should be started before or during operation with dexamethasone ( GRADE A ) . Opioid should be reserved for rescue analgesia only ( GRADE B ) . Gabapentanoids , intraperitoneal local anaesthetic  , and  transversus abdominis plane blocks  are not recommended ( GRADE D ) unless basic analgesia is not possible . Surgically , we recommend low‐pressure pneumoperitoneum , postprocedure saline lavage , and aspiration of pneumoperitoneum ( GRADE A ) . Single‐port incision techniques are not recommended to reduce pain ( GRADE A ) This study explored whether global unidimensional self-report pain scales based on facial expression help children separately estimate the sensory and affective magnitude of post-operative pain . Ninety paediatric elective surgery patients ( in two age groups : 5 - 9 and 10 - 15 years ) used each of four scales to estimate pain intensity and pain affect during the first 2 days after surgery . The four scales were :  Faces Pain Scale ( FPS ) , Facial Affective Scale ( FAS ) , and the Coloured Analogue Scale ( CAS )  ( one for intensity and one for unpleasantness ) . As hypothesised , ratings on the FPS correlated more highly with analogue scale ratings for intensity than for unpleasantness , whereas ratings on the FAS correlated more highly with those on the analogue scale for unpleasantness than for intensity . Factor analysis indicated that although all measures loaded on a single dimension of distress , there was an additional weaker factor corresponding to a unique contribution of the FAS . No systematic age effects were observed . It was concluded that the FPS and the FAS may partly measure different aspects of the postoperative pain experience in children , although shared instrument variance may obscure true estimates of covariation in ratings of intensity and affective magnitude . The clinical relevance of the present results remains to be determined Background Musculoskeletal disorders ( MSDs ) are the leading cause of work disability and sickness absence worldwide . The prevalence of MSDs increases with age , consequently challenging sustainable employability among the growing ageing workforce . Knowledge of feasible and efficient workplace-based interventions to rehabilitate MSD or prevent its consequences is therefore warranted . This systematic review will evaluate the effectiveness of workplace-based interventions on MSDs and its consequences among adult workers with physical and sedentary work tasks , respectively . Methods We will search the following bibliographic data bases : PubMed ( including the data base ‘ MEDLINE ’ ) and Web of Science Core Collection ( including the data bases ‘ Science Citation Index Exp and ed ’ , ‘ Social Sciences Citation Index ’ and ‘ Arts & Humanities Citation Index ’ ) . Manual search es will also be performed . We will include r and omised controlled trials ( RCTs ) and non- RCTs reported in English in which ( 1 ) participants are adult workers with MSD , ( 2 ) interventions are aim ing at rehabilitating pain symptoms of MSD or preventing the consequences of MSD and ( 3 ) interventions are initiated and /or carried out at the workplace . The review will adhere to the ‘ Preferred Reporting Items for Systematic review s and Meta-Analyses ’ ( PRISMA ) guidelines for reporting systematic review s and the Institute for Work and Health ( IWH ) guidelines for workplace-based interventions . For the primary evaluation of the review , the quality assessment and evidence synthesis will conform to the IWH guidelines . Secondary evaluation will include a meta- analysis ( unless the included studies do not allow this due to heterogeneity ) and employ the risk of bias domains recommended by Cochrane along with the Grading of Recommendations , Assessment , Development and Evaluations ( GRADE ) approach on the studies with pain intensity as an outcome . Discussion This systematic review will provide knowledge on effective workplace-based interventions among physical and sedentary workers with MSD . RCTs are considered the most powerful experimental design in clinical trials , but solely including these may be too restrictive to underst and effective workplace-based interventions where r and omised and carefully controlled trials ( RCTs ) are not always possible . In order to maximize practical relevance , the selection process will , therefore , include both RCTs and non- RCTs and the quality assessment and evidence synthesis will conform to IWH guidelines focusing on developing practical guidelines for stakeholders . The result of this work will form the basis for industry-specific evidence -based recommendations on effective workplace-based interventions for rehabilitation of MSDs and its consequences that will later be operationalised into concrete and user-friendly practical tools for workplaces . Systematic review registration International Prospect i ve Register of Systematic Review s ( PROSPERO ) number CRD42018116752 BACKGROUND The Cochrane Collaboration is strongly encouraging the use of a newly developed tool , the Cochrane Collaboration Risk of Bias Tool ( CCRBT ) , for all review groups . However , the psychometric properties of this tool to date have yet to be described . Thus , the objective of this study was to add information about psychometric properties of the CCRBT including inter-rater reliability and concurrent validity , in comparison with the Effective Public Health Practice Project Quality Assessment Tool ( EPHPP ) . METHODS Both tools were used to assess the method ological quality of 20 r and omized controlled trials included in our systematic review of the effectiveness of knowledge translation interventions  to improve the management of cancer pain . Each study assessment was completed independently by two review ers using each tool . We analysed the inter-rater reliability of each tool 's individual domains , as well as final grade assigned to each study . RESULTS The EPHPP had fair inter-rater agreement for individual domains and excellent agreement for the final grade . In contrast , the CCRBT had slight inter-rater agreement for individual domains and fair inter-rater agreement for final grade . Of interest , no agreement between the two tools was evident in their final grade assigned to each study . Although both tools were developed to assess ' quality of the evidence ' , they appear to measure different constructs . CONCLUSIONS Both tools performed quite differently when evaluating the risk of bias or method ological quality of studies in knowledge translation interventions for cancer pain . The newly introduced CCRBT assigned these studies a higher risk of bias . Its psychometric properties need to be more thoroughly vali date d , in a range of research fields , to underst and fully how to interpret results from its application Review question / objective The objective of this review is to synthesize the best available evidence related to the effectiveness of music as pain relieving method among preterm infants during painful procedures in the neonatal intensive care unit . Review questions are : Among preterm infants in the neonatal intensive care unit , is music effective in reducing pain scores ? physiological pain indicators ? behavioural pain indicators ? hormonal pain indicators ? Background Patients and context Preterm infants ( i.e. babies born at or before 37 gestational weeks ) compose a patient group of the most vulnerable to pain . Infants treated in a neonatal intensive care unit ( NICU ) are exposed to a variety of painful procedures ( e.g. heel prick , iv cannula insertion , endotracheal suctioning ) and to environmental stress ( e.g. noise , light ) . Simons et al.1 , for example , described an average 14 + /‐ 4 painful procedures during the first 2 weeks of life within a period of 24 hours among 151 neonates . Many studies have shown that repeated and sustained pain can have direct and long‐term consequences on the neurological and behavior‐oriented development of the neonates during the rapid development phase of the central nervous system . Pain can cause detectable physiological , behavioral and hormonal changes2,3,4 and contribute to the altered development of the pain system during later childhood and adolescence3,4,50 . Instead , live music such as singing is excellent type of music when it is steady , constant , quiet , soothing and directed to the infants6 . Graven7 emphasizes that recorded sound should not replace human voice exposure in the NICU ; therefore , health care providers should provide ample opportunity for the infant to hear parent 's voices live , such as singing or humming , in interactions between the parent and the infant at the bedside . The AmericanAcademy of Pediatrics Committee on Environmental Health has recommended safe levels of sound8 , and these recommendations have been up date d by an expert team of practitioners . Recommendations specify that continuous sound should not exceed an hourly equivalent sound level of 50 A‐weighted decibels (dBA)7,8,9 , and music as an auditory stimulus not exceed 75 dB in NICU6,8,10 . If earphones or other devices are used , sound sources should be kept at reasonable distances from the infant 's ear , played for brief periods and at levels below 55 dB7 . Music listening can be initiated with or without the involvement of a music therapist . In this review , music can be implemented for premature infants by a music therapist or any health care providers and it will include both recorded and live music . Outcomes Regardless of the type of music , several studies have investigated the short term effects of music on preterm infants , including the improvement in physiological outcomes ( e.g. oxygen saturation , heart rate , respiratory rate , and blood pressure ) , as well as in behavioural state ( e.g. crying , facial expression , body movements ) and pain scores6,11,12,13 . For example , Chou et al. 6 showed that premature infants receiving recorded music , that was the combination of womb sounds and the mother singing , with endotracheal suctioning had significantly higher oxygen saturation than when they did not receive music . Butt & Kisilewsky12 compared recorded music involving both the vocal and instrumental version of Brahms lullaby versus no music , and found that infants older than 31 weeks demonstrated significant reduction in heart rate , behavioral state and pain . In the study of Arnon et al.11 the infants receiving live music , compared with infants receiving recorded music or no music , had significantly reduced heart rate and behavioral scores during the post‐intervention period . Live music comprised of a lullaby sang by the female voice with frame drum and an accompanying harp . The same music was played by a tape recorder . Live music showed significant benefits , whereas no statistically significant changes were found for the recorded music and control groups . Teckenberg‐Jansson et al.13 indicated that music therapy combined with kangaroo care  decreased the pulse , slowed down the respiration and increased the transcutaneous oxygen saturation in preterm infants . The musical instruments used were a lyre and a female human voice , which hummed or sang . There is evidence that music has also positive consequences on long‐term outcomes , including length of hospitalization , weight gain , and non‐nutritive sucking10,13,14,15 . For example , in the study of Caine16 the preterm infants received music stimulation which consisted of recorded vocal music ( including lullabies and children 's music ) and routine auditory stimulation . Exposure to the music stimulation had many positive effects on preterm infants , such as it increased daily average weight , formula and caloric intake , and significantly reduced total hospital stays and stress behaviors for the experimental group . In addition , according to Lubetzky et al.10 exposure to music by Mozart significantly lowered energy expenditure among healthy preterm infants . Hartling et al.17 have published a systematic review on the efficacy of music for medical indicators in term and preterm neonates . Nine r and omized trials ( 1989‐2006 ) were included . According to the results of this review music may have positive effects on physiological parameters and behavioral states , and may reduce pain and improve oral feeding rates among the premature infants . The effects of music were evaluated during medical procedures ( circumcision , heel prick ) and for other indicators . In addition , Cignacco et al.18 conducted a systematic literature review on the efficacy of non‐pharmacological interventions in the management of procedural pain in preterm and term neonates during the period from 1984 to 2004 . According to this review there was no clear evidence that the method of music could have a pain‐alleviating effect on neonates . In the Cochrane Library , one systematic review is also available up to year of 2011 concerning  non‐pharmacological  management of infants and young children ( preterm , neonate , older up to three years ) during procedural pain19 , but this review did not consider music as an intervention . To date , there is also one meta‐ analysis published by St and ley20 concerning the efficacy of music therapy  for premature infants during the period from 1950 to 1999 . It concluded that music was beneficial for many outcomes among the preterm infants in the NICU . However , the results of this review were limited by the poor method ological quality of the included studies , and unclear reporting on the phases of review . In our systematic review , studies published in 2000 and after will be considered for inclusion in the review . The number of the RCT 's concerning the effectiveness of music  among the preterm infants in NICU is especially increased during the last few years , and these studies have not included in the previous systematic review s and meta‐ analysis & NA ; The efficacy of ketorolac , a non‐steroidal anti‐inflammatory drug , in the management of moderate to severe pain in adults , has led us to conduct a trial of this analgesic in children following tonsillectomy . Children were r and omized to receive intramuscular ( i.m . ) ketorolac ( 1 mg/kg , EXP group , n = 45 ) or saline ( CTL group , n = 42 ) at the completion of surgery . Intravenous ( i.v . ) fentanyl ( 0.5 & mgr;g/kg/dose ) was administered in repeated doses postoperatively . Pain intensity was measured using both the Oucher and the Children 's Hospital of Eastern Ontario Pain Scale ( CHEOPS ) to allow for comparison between self‐report and behavioral measures of pain intensity . Severity of postoperative bleeding was measured using a 4‐point rating scale . The EXP group had a significant reduction in total fentanyl dose ( mean : 35.9 & mgr;g ) compared to the CTL group ( mean : 48.3 & mgr;g , t = −2.21 , P < 0.03 ) . There was a statistically significant decrease in pre‐fentanyl CHEOPS scores in the Post‐Anesthesia Care Unit ( PACU ) in the ketorolac group ( F ( 2,30 ) = 5.34 , P < 0.01 ) , but not in the saline group ( F ( 2.24 ) = 2.46 , P > 0.05 ) . In the first hour postoperatively , the CHEOPS demonstrated significant decreases in pain intensity scores in response to opioids , in both groups . In the PACU , children were unable to provide a self‐report of pain intensity potentially due to a variety of factors ( e.g. , emergence delirium , agitation , excitement , sedation , and /or pain ) . However , during the remainder of the postoperative stay , the photographic scale of the Oucher was a more valid measure of pain intensity than the CHEOPS . There were no differences between the 2 groups in the severity of postoperative bleeding . Children in the EXP group were discharged significantly earlier ( i.e. , 30 min , t = −2.22 , P < 0.03 ) . Our data demonstrate that i.m . administration of ketorolac , at the end of surgery , significantly reduces opioid requirements and shortens length of stay without any evidence of increased bleeding . In addition , our data suggest that the patient 's altered level of consciousness and attention span may diminish the utility of self‐report measures of  pain intensity  in the immediate postoperative period Low back pain is the fifth most common reason for all physician visits in the United States ( 1 , 2 ) . Approximately one quarter of U.S. adults reported having low back pain lasting at least 1 whole day in the past 3 months ( 2 ) , and 7.6 % reported at least 1 episode of severe acute low back pain ( see Glossary ) within a 1-year period ( 3 ) . Low back pain is also very costly : Total incremental direct health care costs attributable to low back pain in the U.S. were estimated at $ 26.3 billion in 1998 ( 4 ) . In addition , indirect costs related to days lost from work are substantial , with approximately 2 % of the U.S. work force compensated for back injuries each year ( 5 ) . Many patients have self-limited episodes of acute low back pain and do not seek medical care ( 3 ) . Among those who do seek medical care , pain , disability , and return to work typically improve rapidly in the first month ( 6 ) . However , up to one third of patients report persistent back pain of at least moderate intensity 1 year after an acute episode , and 1 in 5 report substantial limitations in activity ( 7 ) . Approximately 5 % of the people with back pain disability account for 75 % of the costs associated with low back pain ( 8) . Many options are available for evaluation and management of low back pain . However , there has been little consensus , either within or between specialties , on appropriate clinical evaluation ( 9 ) and management ( 10 ) of low back pain . Numerous studies show unexplained , large variations in use of diagnostic tests and treatments ( 11 , 12 ) . Despite wide variations in practice , patients seem to experience broadly similar outcomes , although costs of care can differ substantially among and within specialties ( 13 , 14 ) . The purpose of this guideline is to present the available evidence for evaluation and management of acute and chronic low back pain ( see Glossary ) in primary care setting s. The target audience for this guideline is all clinicians caring for patients with low ( lumbar ) back pain of any duration , either with or without leg pain . The target patient population is adults with acute and chronic low back pain not associated with major trauma . Children or adolescents with low back pain ; pregnant women ; and patients with low back pain from sources outside the back ( nonspinal low back pain ) , fibromyalgia or other myofascial pain syndromes , and thoracic or cervical back pain are not included . These recommendations are based on a systematic evidence review summarized in 2 background papers by Chou and colleagues in this issue ( 15 , 16 ) from an evidence report by the American Pain Society ( 17 ) . The evidence report ( 17 ) discusses the evidence for the evaluation , and the 2 background papers ( 15 , 16 ) summarize the evidence for management . Methods The literature search for this guideline included studies from MEDLINE ( 1966 through November 2006 ) , the Cochrane Data base of Systematic Review s , the Cochrane Central Register of Controlled Trials , and EMBASE . The literature search included all English- language articles reporting on r and omized , controlled trials of nonpregnant adults ( age > 18 years ) with low back pain ( alone or with leg pain ) of any duration that evaluated a target medication and reported at least 1 of the following outcomes : back-specific function , generic health status , pain , work disability , or patient satisfaction .  The American College of Physicians ( ACP ) and the American Pain Society ( APS ) convened a multidisciplinary panel of experts to develop the key questions and scope used to guide the evidence report , review its results , and formulate recommendations . The background papers by Chou and colleagues ( 15 , 16 ) provide details about the methods used for the systematic evidence review . This guideline grade s its recommendations by using the ACP 's clinical practice guidelines grading system , adapted from the classification developed by the Grading of Recommendations , Assessment , Development , and Evaluation ( GRADE ) work group ( Appendix Table 1 ) ( 18 ) . The evidence in this guideline was first evaluated by the ACP/APS panel by using a system adopted from the U.S. Preventive Services Task Force for grading strength of evidence , estimating magnitude of benefits , and assigning summary ratings ( Appendix Tables 2 , 3 , and 4 ) ( 19 ) . The evidence was independently review ed by the ACP 's Clinical Efficacy Assessment Subcommittee . The ratings for individual low back pain interventions discussed in this guideline are summarized in Appendix Table 5 for acute low back pain ( < 4 weeks ' duration ) and in Appendix Table 6 for chronic/subacute low back pain ( > 4 weeks ' duration ) . This guideline considered interventions to have proven benefits only when they were supported by at least fair- quality evidence and were associated with at least moderate benefits ( or small benefits but no significant harms , costs , or burdens ) . Figures 1 and 2 present an accompanying algorithm . Appendix Table 1 . The American College of Physicians Clinical Practice Guidelines Grading System Appendix Table 2 . Methods for Grading the Strength of the Overall Evidence for an Intervention Appendix Table 3 . Definitions for Estimating Magnitude of Effects Appendix Table 4 . Recommendations and Summary Ratings Appendix Table 5 . Level of Evidence and Summary Grade s for Noninvasive Interventions in Patients with Acute Low Back Pain Appendix Table 6 . Level of Evidence and Summary Grade s for Noninvasive Interventions in Patients with Chronic or Subacute Low Back Pain Figure 1 . Initial evaluation of low back pain ( LBP Figure 2 . Management of low back pain ( LBP Recommendations : Evaluation of Low Back Pain Recommendation 1 : Clinicians should conduct a focused history and physical examination to help place patients with low back pain into 1 of 3 broad categories : nonspecific low back pain , back pain potentially associated with radiculopathy or spinal stenosis , or back pain potentially associated with another specific spinal cause . The history should include assessment of psychosocial risk factors , which predict risk for chronic disabling back pain ( strong recommendation , moderate- quality evidence ) . More than 85 % of patients who present to primary care have low back pain that can not reliably be attributed to a specific disease or spinal abnormality ( nonspecific low back pain [ see Glossary ] ) ( 20 ) . Attempts to identify specific anatomical sources of low back pain in such patients have not been vali date d in rigorous studies , and classification schemes frequently conflict with one another ( 21 ) . Moreover , no evidence suggests that labeling most patients with low back pain by using specific anatomical diagnoses improves outcomes . In a minority of patients presenting for initial evaluation in a primary care setting , low back pain is caused by a specific disorder , such as cancer ( approximately 0.7 % of cases ) , compression fracture ( 4 % ) , or spinal infection ( 0.01 % ) ( 22 ) . Estimates for prevalence of ankylosing spondylitis in primary care patients range from 0.3 % ( 22 ) to 5 % ( 23 ) . Spinal stenosis ( see Glossary ) and symptomatic herniated disc ( see Glossary ) are present in about 3 % and 4 % of patients , respectively . The cauda equina syndrome ( see Glossary ) is most commonly associated with massive midline disc herniation but is rare , with an estimated prevalence of 0.04 % among patients with low back pain ( 24 ) . A practical approach to assessment is to do a focused history and physical examination to determine the likelihood of specific underlying conditions and measure the presence and level of neurologic involvement ( 24 , 25 ) . Such an approach facilitates classification of patients into 1 of 3 broad categories : nonspecific low back pain , back pain potentially associated with radiculopathy ( see Glossary ) or spinal stenosis ( suggested by the presence of sciatica [ see Glossary ] or pseudoclaudication ) , and back pain potentially associated with another specific spinal cause . The latter category includes the small proportion of patients with serious or progressive neurologic deficits or underlying conditions requiring prompt evaluation ( such as tumor , infection , or the cauda equina syndrome ) , as well as patients with other conditions that may respond to specific treatments ( such as ankylosing spondylitis or vertebral compression fracture ) . Diagnostic triage into 1 of these 3 categories helps guide subsequent decision making . Clinicians should inquire about the location of pain , frequency of symptoms , and duration of pain , as well as any history of previous symptoms , treatment , and response to treatment . The possibility of low back pain due to problems outside the back , such as pancreatitis , nephrolithiasis , or aortic aneurysm , or systemic illnesses , such as endocarditis or viral syndromes , should be considered . All patients should be evaluated for the presence of rapidly progressive or severe neurologic deficits , including motor deficits at more than 1 level , fecal incontinence , and bladder dysfunction . The most frequent finding in the cauda equina syndrome is urinary retention ( 90 % sensitivity ) ( 24 ) . In patients without urinary retention , the probability of the cauda equina syndrome is approximately 1 in 10000 . Clinicians should also ask about risk factors for cancer and infection . In a large , prospect i ve study from a primary care setting , a history of cancer ( positive likelihood ratio , 14.7 ) , unexplained weight loss ( positive likelihood ratio , 2.7 ) , failure to improve after 1 month ( positive likelihood ratio , 3.0 ) , and age older than 50 years ( positive likelihood ratio , 2.7 ) were each associated with a higher likelihood for cancer ( 26 ) . The posttest probability of cancer in patients presenting with back pain increases from approximately 0.7 % to 9 % in patients with a history of cancer ( not including nonmelanoma skin cancer ) . In patients with any 1 of the other 3 risk factors , the likelihood of cancer only increases to approximately 1.2 % ( 26 ) . Features predicting the presence of vertebral infection have not been well studied & NA ; A new instrument was design ed to provide a practical clinical measure for assessing children 's pain intensity and pain affect .  The pocket size measure includes a Coloured Analogue Scale ( CAS ) to assess intensity and a facial affective scale to assess the aversive component of pain . Both scales have numerical ratings on the back , so that the person administering it can quickly note the numbers that represent a child 's pain . This study was conducted to determine : the validity of the new instrument by evaluating the psychophysical properties of the intensity scale and by evaluating the discriminant validity of the intensity and affective scales . Since visual analogue scales ( VAS ) are valid and reliable measures for assessing children 's pain , children 's ability to use the new analog scale was compared with their performance on a VAS . Children 's ability to rate pain affect using an affective scale , in which the 9 faces on a Facial Affective Scale ( FAS ) are presented in an ordered sequence from least to most distressed , was compared to their performance on the original FAS , in which the same faces were presented in a r and om order . Using a parallel groups design , 104 children ( 5–16 years ; 60 female , 44 male ; 51 healthy and 53 with recurrent headaches ) were r and omized into two groups : CAS or VAS . Children used the assigned scale to complete a calibration task , in which they rated the sizes of 7 circles varying in area ( 491 , 804 , 1385 , 2923 , 3848 , 5675 and 7854 mm2 ) . The psychophysical function relating perceived circle size to actual physical size was determined for the CAS and VAS . Children 's  CAS and VAS  responses on the calibration task yielded similar mathematical relationships ; & PHgr;cas = 0.035I0.87 , & PHgr;vas = 0.027I0.89 , where & PHgr ; = perceived magnitude and I = stimulus intensity . The R2 values were 0.921 and 0.922 for the CAS and VAS groups , respectively . Analyses of covariance revealed no significant differences in the characteristics of these relationships , i.e. , R2 , slope , or y intercept , by scale type . Children used the same scale to complete the Children 's Pain Inventory ( CPI ) , in which they rated the intensity and affect of 16 painful events ( varying in nature and extent of tissue damage ) . Children 's  CAS and VAS  responses on the CPI were similar . Analyses of covariance indicated that there were no differences in either intensity or affective ratings by scale type . However , the mean number of painful events experienced by children increased significantly with age ( P = 0.0001 ) . Intensity ratings decreased significantly with age ( P = 0.002 ) , but affective ratings did not vary with age . The new instrument has equivalent psychometric properties to a 165 mm VAS . However , the CAS was rated as easier to administer and score than the VAS , so it may be more practical for routine clinical use . Since the CAS has fulfilled the first two criteria for a pain measure ( psychophysical properties and discriminant validity ) , it is ethical to proceed with the formal definitive test for construct validity , in which children from various clinical population s use the CAS scale to assess their own pain ABSTRACT Cognitive – behavioral therapy ( CBT ) interventions show promise for decreasing chronic pain in youth . However , the availability of CBT is limited by many factors including distance to major treatment centers and expense . This study evaluates a more accessible treatment approach for chronic pediatric pain using an Internet‐delivered family CBT intervention .  Participants included 48 children , aged 11–17 years , with chronic headache , abdominal , or musculoskeletal pain and associated functional disability , and their parents . Children were r and omly assigned to a wait‐list control group or an Internet treatment group . Primary treatment outcomes were pain intensity ratings ( 0–10 NRS ) and activity limitations on the Child Activity Limitations Interview , both completed via an online daily diary . In addition to their medical care , the Internet treatment group completed 8 weeks of online modules including relaxation training , cognitive strategies , parent operant techniques , communication strategies , and sleep and activity interventions . Youth r and omized to the wait‐list control group continued with the current medical care only . Findings demonstrated significantly greater reduction in activity limitations and pain intensity at post‐treatment for the Internet treatment group and these effects were maintained at the three‐month follow‐up . Rate of clinical ly significant improvement in pain was also greater for the Internet treatment group than for the wait‐list control group . There were no significant group differences in parental protectiveness or child depressive symptoms post‐treatment . Internet treatment was rated as acceptable by all children and parents . Findings support the efficacy and acceptability of Internet delivery of family CBT for reducing pain and improving function among children and adolescents with chronic pain The objective of this study was to test the efficacy and suitability of virtual reality ( VR ) as a pain distraction for pediatric intravenous ( i.v . ) placement . Twenty children ( 12 boys , 8 girls ) requiring i.v . placement for a magnetic resonance imaging/computed tomography ( MRI/CT ) scan were r and omly assigned to two conditions : ( 1 ) VR distraction using Street Luge ( 5DT ) , presented via a head-mounted display , or ( 2 ) st and ard of care ( topical anesthetic ) with no distraction .  Children , their parents , and nurses completed self-report question naires that assessed numerous health-related outcomes . Responses from the Faces Pain Scale-Revised indicated a fourfold increase in affective pain within the control condition ; by contrast , no significant differences were detected within the VR condition . Significant associations between multiple measures of anticipatory anxiety , affective pain , i.v . pain intensity , and measures of past procedural pain provided support for the complex interplay of a multimodal assessment of pain perception . There was also a sufficient amount of evidence supporting the efficacy of Street Luge as a pediatric pain distraction tool during i.v . placement : an adequate level of presence , no simulator sickness , and significantly more child- , parent- , and nurse-reported satisfaction with pain management . VR pain distraction was positively endorsed by all reporters and is a promising tool for decreasing pain , and anxiety in children undergoing acute medical interventions . However , further research with larger sample sizes and other routine medical procedures is warranted & NA ; Adverse events in r and omized controlled trials of noninvasive , pharmacologic analgesics are frequently incompletely or inconsistently reported . A comprehensive reporting checklist is proposed to improve disclosure of adverse effects . & NA ; The development of valid and informative treatment risk – benefit profiles requires consistent and thorough information about adverse event ( AE ) assessment and participants ’ AEs during r and omized controlled trials ( RCTs ) . Despite a 2004 extension of the Consoli date d St and ards of Reporting Trials ( CONSORT ) statement recommending the specific AE information that investigators should report , there is little evidence that analgesic RCTs adequately adhere to these recommendations . This systematic review builds on prior recommendations by describing a comprehensive checklist for AE reporting developed to capture clinical ly important AE information . Using this checklist , we coded AE assessment methods and reporting in all 80 double‐blind RCTs of noninvasive pharmacologic treatments published in the European Journal of Pain , Journal of Pain , and PAIN ® from 2006 to 2011 . Across all trials , reports of AEs were frequently incomplete , inconsistent across trials , and , in some cases , missing . For example , > 40 % of trials failed to report any information on serious adverse events . Trials of participants with acute or chronic pain conditions and industry‐sponsored trials typically provided more and better‐ quality AE data than trials involving pain‐free volunteers or trials that were not industry sponsored . The results of this review suggest that improved AE reporting is needed in analgesic RCTs . We developed an ACTTION ( Analgesic , Anesthetic , and Addiction Clinical Trial Translations , Innovations , Opportunities , and Networks ) AE reporting checklist that is intended to assist investigators in thoroughly and consistently capturing and reporting these critically important data in publications
Based on available evidence , the NRS-11 , FPS-R , and CAS were strongly recommended for self-report of acute pain .
Only weak recommendations could be made for self-report measures for postoperative and chronic pain .
No measures were recommended for children younger than 6 years , identifying a need for further measurement refinement in this age range .
Abstract In 2006 , PAIN published a systematic review of the measurement properties of self-report pain intensity measures  in children and adolescents ( Stinson JN , Kavanagh T , Yamada J , Gill N , Stevens B. Systematic review of the psychometric properties , interpretability and feasibility of self-report pain intensity measures for use in clinical trials in children and adolescents .
Key developments in pediatric pain necessitate an up date of this work , most notably growing use of the 11-point numeric rating scale ( NRS-11 ) .
Our aim was to review the measurement properties of single-item self-report pain intensity measures in children 3 to 18 years old .
A secondary aim was to develop evidence -based recommendations for measurement of child and adolescent self-report of acute , postoperative , and chronic pain .