Physical restraints versus seclusion room for management of people with acute aggression or agitation due to psychotic illness (TREC-SAVE): a randomized trial. Current practices in managing acutely disturbed patients at three hospitals in Rio de Janeiro-Brazil: a prevalence study Rapid tranquillisation in psychiatric emergency settings in Brazil: pragmatic randomised controlled trial of intramuscular haloperidol versus intramuscular haloperidol plus promethazine Head-to-head comparison of aggressive conventional therapy and three biological treatments and comparison of two de-escalation strategies in patients who respond to treatment: study protocol for a multicenter, randomized, open-label, blinded-assessor, phase 4 study Factors associated with the use of physical restraints for agitated patients in psychiatric emergency rooms. Rapid tranquillisation for agitated patients in emergency psychiatric rooms: a randomised trial of midazolam versus haloperidol plus promethazine Therapeutic Touch and Agitation in Individuals With Alzheimer's Disease Non-pharmacological management of behavioural symptoms in nursing homes.
BACKGROUND After de-escalation techniques have failed , restraints , seclusion and /or rapid tranquillization may be used for people whose aggression is due to psychosis . Most coercive acts of health care have not been evaluated in trials . METHOD People admitted to the emergency room of Instituto Philippe Pinel , Rio de Janeiro , Brazil , whose aggression/agitation was thought due to psychosis and for whom staff were unsure if best to restrict using physical restraints or a seclusion room  , were r and omly allocated to one or the other and followed up to 14 days . The primary outcomes were ' no need to change intervention early - within 1 h ' and ' not restricted by 4 h ' . RESULTS A total of 105 people were r and omized . Two-thirds of the people secluded were able to be fully managed in this way . Even taking into account the move out of seclusion into restraints , this study provides evidence that embarking on the less restrictive care pathway ( seclusion ) does not increase overall time in restriction of some sort [ not restricted by 4 h : relative risk 1.09 , 95 % confidence interval 0.75 - 1.58 ; mean time to release : restraints 337.6 ( s.d.=298.2 ) min , seclusion room 316.3 ( s.d.=264.5 ) min , p=0.48 ] . Participants tended to be more satisfied with their care in the seclusion group ( 17.0 % v. 11.1 % ) but this did not reach conventional levels of statistical significance ( p=0.42 ) . CONCLUSIONS This study should be replicated , but suggests that opting for the least restrictive option in circumstances where there is clinical doubt does not harm or prolong coercion Background The medical management of aggressive and violent behaviour is a critical situation for which there is little evidence . In order to prepare for a r and omised trial , due to start in the psychiatric emergency rooms of Rio de Janeiro in 2001 , a survey of current practice was necessary . Methods A seven day survey of pharmacological management of aggressive people with psychosis in the emergency rooms of all four public psychiatric hospitals in Rio de Janeiro , Brazil . Results In one hospital data were not available . Of the 764 people with psychosis attending these ERs , 74 were given IM medication for rapid tranquillisation ( 9.7 % , 2.1/week/100,000 ) . A haloperidol-promethazine mix ( with or without other drugs ) was used for the majority of patients ( 83 % ) . Conclusion The haloperidol-promethazine mix , given intramuscularly for rapid tranquilization , is prevalent in Rio , where it is considered both safe and efficient . However , scientific evaluation of all pharmacological approaches to rapid tranquilization of psychotic people is inadequate or incomplete and a r and omized trial of IM haloperidol-promethazine is overdue Objective To determine whether haloperidol alone results in swifter and safer tranquillisation and sedation than haloperidol plus promethazine . Design Pragmatic r and omised open trial ( January-July 2004 ) . Setting Psychiatric emergency room , Rio de Janeiro , Brazil . Participants 316 patients who needed urgent intramuscular sedation because of agitation , dangerous behaviour , or both . Interventions Open treatment with intramuscular haloperidol 5 - 10 mg or intramuscular haloperidol 5 - 10 mg plus intramuscular promethazine up to 50 mg ; doses were at the discretion of the prescribing clinician . Main outcome measures The primary outcome was proportion tranquil or asleep by 20 minutes . Secondary outcomes were asleep by 20 minutes ; tranquil or asleep by 40 , 60 , and 120 minutes ; physically restrained or given additional drugs within 2 hours ; severe adverse events ; another episode of agitation or aggression ; additional visit from the doctor during the subsequent 24 hours ; overall antipsychotic load in the first 24 hours ; and still in hospital after 2 weeks . Results Primary outcome data were available for 311 ( 98.4 % ) people , 77 % of whom were thought to have a psychotic illness . Patients allocated haloperidol plus promethazine were more likely to be tranquil or asleep by 20 minutes than those who received intramuscular haloperidol alone ( relative risk 1.30 , 95 % confidence interval 1.10 to 1.55 ; number needed to treat 6 , 95 % confidence interval 4 to 16 ; P=0.002 ) . No differences were found after 20 minutes . However , 10 cases of acute dystonia occurred , all in the haloperidol alone group . Conclusions Haloperidol plus promethazine is a better option than haloperidol alone in terms of speed of onset of action and safety . Enough data are now available to change guidelines that continue to recommend treatments that leave people exposed to longer periods of aggression than necessary and patients vulnerable to distressing and unsafe adverse effects . Trial registration Current Controlled Trials IS RCT N83261243 Background New targeted therapies and improved treatment strategies have dramatically improved the outcomes of patients with rheumatoid arthritis ( RA ) . However , it is unknown whether different early aggressive interventions can induce stable remission or a low-active disease state that can be maintained with conventional synthetic disease-modifying antirheumatic drug ( csDMARD ) therapy , and whether they differ in efficacy and safety . The Nordic Rheumatic Diseases Strategy Trials And Registries ( NORD-STAR ) study will assess and compare ( 1 ) the proportion of patients who achieve remission in a head-to-head comparison between csDMARD plus glucocorticoid therapy and three different biological DMARD ( bDMARD ) therapies with different modes of action and ( 2 ) two de-escalation strategies in patients who respond to first-line therapy . Methods / design In a pragmatic , 80–160-week , multicenter , r and omized , open-label , assessor-blinded , phase 4 study , 800 patients with early RA ( symptom duration less than 24 months ) are r and omized 1:1:1:1 to one of four different treatment arms : ( 1 ) aggressive csDMARD therapy with methotrexate + sulphasalazine + hydroxychloroquine + i.a . glucocorticoids ( arm 1A ) or methotrexate + prednisolone p.o . ( arm 1B ) , ( 2 ) methotrexate + certolizumab-pegol , ( 3 ) methotrexate + abatacept , or ( 4 ) methotrexate + tocilizumab . The primary clinical endpoint is the proportion of patients reaching Clinical Disease Activity Index ( CDAI ) remission at week 24 . Patients in stable remission over 24 consecutive weeks enter part 2 of the study earliest after 48 weeks . Patients not achieving sustained CDAI remission over 24 consecutive weeks , exit the study after 80 weeks . In part 2 , patients are re-r and omized to two different de-escalation strategies , either immediate or delayed ( after 24 weeks ) tapering , followed by cessation of study medication . All patients remain on stable doses of methotrexate  . The primary clinical endpoint in part 2 is the proportion of patients in remission ( CDAI ≤2.8 ) 24 weeks after initiating treatment de-escalation . Radiographic assessment will be performed regularly throughout the trial , and blood and urine sample s will be stored in a biobank for later biomarker analyses . Discussion NORD-STAR is the first investigator-initiated , r and omized , early RA trial to compare ( 1 ) csDMARD and three different bDMARD therapies head to head and ( 2 ) two different de-escalation strategies . The trial has the potential to identify which treatment strategy to apply in early RA to achieve the best possible outcomes for both patients and society . Trial registration NCT01491815 and NCT02466581 . Registered on 8 December 2011 and May 2015 , respectively . EudraCT : 2011 - 004720 - OBJECTIVE To examine factors associated with physical restraint in psychiatric emergency rooms . METHOD We extracted variables likely to predict use of physical restraints from a large r and omised trial undertaken in three psychiatric emergency rooms in Rio de Janeiro . We fitted a Bayesian binary multivariate model using only variables clearly preceding the restraints . RESULTS Of 301 agitated , aggressive people admitted to emergency rooms , 73 ( 24 % ) were restrained during the first 2 h of admission . In Rio , younger people ( OR=1.03 for each year younger ) , exhibiting intense ( OR=2.53 ) or extreme agitation ( OR=7.71 ) , thought to result from substance misuse ( OR=1.75 ) or diagnoses other than psychosis ( OR=1.88 ) , arriving in the morning ( OR=1.64 ) were at greater risk of  physical restraints  than older , less severely aggressive or agitated people , arriving at the hospital during the afternoon or night . Hospital , gender , first admission to hospital and medication were not associated with risk of being restrained . CONCLUSION Restraint practice s in Rio are predictable and based on a limited clinical assessment . Predictive factors for physical restraint may vary worldwide , but should be monitored and studied to assist training , and to establish programs to evaluate and refine this controversial practice Abstract Objective To compare two widely used drug treatments for people with aggression or agitation due to mental illness . Design Pragmatic , r and omised clinical trial . Setting Three psychiatric emergency rooms in Rio de Janeiro , Brazil . Subjects 301 aggressive or agitated people . Interventions Open treatment with intramuscular midazolam or intramuscular haloperidol plus promethazine . Main outcome measures Patients tranquil or se date d at 20 minutes . Secondary outcomes : patients tranquil or asleep by 40 , 60 , and 120 minutes ; restrained or given extra drugs within 2 hours ; severe adverse events ; another episode of agitation or aggression ; needing extra visits from doctor during first 24 hours ; overall antipsychotic load in first 24 hours ; and not discharged by two weeks . Results 151 patients were r and omised to midazolam , and 150 to haloperidol-promethazine mix . Follow up for the primary outcome was available for 298 ( 99 % ) : 134/151 ( 89 % ) of patients given midazolam were tranquil or asleep after 20 minutes compared with 101/150 ( 67 % ) of those given haloperidol plus promethazine ( relative risk 1.32 ( 95 % confidence interval 1.16 to 1.49 ) ) . By 40 minutes , midazolam still had a statistically and clinical ly significant 13 % relative advantage ( 1.13 ( 1.01 to 1.26 ) ) . After 1 hour , about 90 % of both groups were tranquil or asleep . One important adverse event occurred in each group : a patient given midazolam had transient respiratory depression , and one given haloperidol-promethazine had a gr and e mal seizure . Conclusions Both treatments were effective . Midazolam was more rapidly sedating than haloperidol-promethazine , reducing the time people are exposed to aggression . Adverse effects and re sources to deal with them should be considered in the choice of the treatment Limited effective strategies exist to alleviate or treat disruptive behaviors in people with Alzheimer 's disease . Fifty-one residents of a long-term care facility with Alzheimer 's disease were r and omly assigned to one of three intervention groups . A multiple time series , blinded , experimental design was used to compare the effectiveness of therapeutic touch , simulated therapeutic touch , and usual care on disruptive behavior . Three forms of disruptive behavior comprised the dependent variables : physical aggression , physical nonaggression , and verbal agitation . Physical nonaggressive behaviors decreased significantly in those residents who received therapeutic touch compared with those who received the simulated version and the usual care . No significant differences in physically aggressive and verbally agitated behaviors were observed across the three study groups . The study provided preliminary evidence for the potential for therapeutic touch in dealing with agitated behaviors by people with dementia . Research ers and practitioners must consider a broad array of strategies to deal with these behaviors BACKGROUND Behavioural and psychological symptoms of dementia ( BPSD ) are often reported in institutions for the elderly . OBJECTIVE To evaluate the effectiveness of a staff education intervention to manage BPSD in older people with a diagnosis of dementia . METHODS The trial was conducted in 16 nursing homes ; 306 patients with a diagnosis of dementia and presenting BPSD were selected . Nursing homes were r and omly allocated to an intervention group or a control group . An 8-week staff education and training programme was conducted in the nursing homes in the intervention group . The main outcome measures were the Cohen-Mansfield Agitation Inventory ( CMAI ) and an Observation Scale ( OS ) score . Assessment s were done at baseline ( W0 ) , at the end of the ' intervention ' period ( W8 ) and 12 weeks after ( W20 ) . RESULTS There was a significant decrease in the global CMAI score between baseline and W8 ( -7.8 ; p > 0.01 ) and between baseline and W20 ( -6.5 ; p > 0.01 ) in the intervention group but not in the control group . Results of mixed linear models showed that the CMAI global score , the CMAI physically non-aggressive behaviours subscale score and verbally non-aggressive behaviours subscale score significantly decreased in the intervention group ( p < 0.001 ) although there was no significant evolution in the control group . Direct assessment with the OS produced the same pattern of results , with a significant decrease only in the intervention group . CONCLUSION The intervention reduced BPSD in severely demented nursing home residents and this effect was still present 3 months after the end of the programme
Using de-escalation techniques  for people with psychosis induced aggression or agitation appears to be accepted as good clinical practice but is not supported by evidence from r and omised trials .
BACKGROUND Aggression is a disposition , a willingness to inflict harm , regardless of whether this is behaviourally or verbally expressed and regardless of whether physical harm is sustained .
De-escalation is a psychosocial intervention for managing people with disturbed or aggressive behaviour .
Secondary management strategies such as rapid tranquillisation , physical intervention and seclusion should only be considered once de-escalation and other strategies have failed to calm the service user .
OBJECTIVES To investigate the effects of de-escalation techniques in the short-term management of aggression or agitation  thought or likely to be due to psychosis .
It is unclear why it has remained such an under- research ed area .