A randomized, controlled trial of nebulized terbutaline for the first acute bronchiolitis in infants less than 12-months-old. Dexamethasone and salbutamol in the treatment of acute wheezing in infants. The efficacy of nebulized metaproterenol in wheezing infants and young children. Efficacy of salbutamol and ipratropium bromide in the management of acute bronchiolitis--a clinical trial. Use of nebulized bronchodilators in infants under 1 year of age: analysis of four forms of therapy. Oral salbutamol for symptomatic relief in mild bronchiolitis a double blind randomized placebo controlled trial. Nebulized albuterol in acute bronchiolitis. Randomized, double-blind, placebo-controlled trial of oral albuterol in infants with mild-to-moderate acute viral bronchiolitis. A randomized, controlled trial of the effectiveness of nebulized therapy with epinephrine compared with albuterol and saline in infants hospitalized for acute viral bronchiolitis. Ineffectiveness of ipratropium bromide in acute bronchiolitis. Salbutamol or mist in acute bronchiolitis. High volume normal saline alone is as effective as nebulized salbutamol-normal saline, epinephrine-normal saline, and 3% saline in mild bronchiolitis. The use of nebulized albuterol in wheezing infants. Randomized, placebo-controlled trial of albuterol and epinephrine at equipotent beta-2 agonist doses in acute bronchiolitis. Tidal breathing flow-volume loops in bronchiolitis in infancy: the effect of albuterol [ISRCTN47364493]. The use of albuterol in hospitalized infants with bronchiolitis. Efficacy of bronchodilators in the treatment of bronchiolitis. Bronchodilators for treatment of mild bronchiolitis: a factorial randomised trial. Effect of salbutamol on oxygen saturation in bronchiolitis. Randomized trial of salbutamol in acute bronchiolitis. A prospective randomized controlled blinded study of three bronchodilators in infants with respiratory syncytial virus bronchiolitis on mechanical ventilation. The role of bronchodilators in the management of bronchiolitis: a clinical trial. Efficacy of albuterol in the management of bronchiolitis. Oral versus nebulized albuterol in the management of bronchiolitis in Egypt.
Despite the common clinical practice, the available evidence on the efficacy of bronchodilators therapy for bronchiolitis is conflicting. The aim of this study is to evaluate the efficacy of nebulized terbutaline in bronchiolitis as measured by improvement in clinical score, oxygen saturation or reduction in duration of hospitalization.
                This prospective, double blind, placebo controlled, randomized clinical trial was performed at Children's Hospital of Tunis from December 2004 to April 2006. A total of 35 patients less than 12 months of age with diagnosis of moderately severe bronchiolitis were enrolled and assigned to receive nebulized terbutaline or normal saline placebo at admission (T0), at 30 minutes after admission (T30) and every four hours during a study period. Outcome measurements included: Respiratory Distress Assessment Instrument (RDAI) score, respiratory rate, oxygen saturation, heart rate and the duration of hospitalization.
                There were no significant difference between terbutaline and placebo at baseline, T30 min, T60 min, and T120 min after start study in RDAI score, oxygen saturation in room air, rate respiratory and heart rate. There was no difference in duration of hospitalization.
                Nebulized terbutaline therapy does not appear effective in treating moderately ill infants with the first acute bronchiolitis. Thirty-two infants, aged 1 to 12 months, hospitalized with acute wheezing, were studied. They were randomly divided into four treatment groups of eight patients each. The treatments were intramuscular dexamethasone or placebo (double-blind), and salbutamol (oral and inhaled), or none (open), in all four possible combinations. The study was carried out as a randomized block design with eight blocks of four infants each, matched by age and clinical score. Average daily improvements, as reflected by changes in the clinical score and length of hospital stay, was essentially the same for infants treated with placebo, salbutamol alone, and dexamethasone alone. However, combined salbutamol-dexamethasone treatment resulted in more than twice the rate of improvement of the other treatments. The difference was statistically highly significant (P less than .01). Furthermore, the response of this combined treatment was observed within 24 hours; none of the ten infants in whom there was no significant improvement within 48 hours and neither of the two patients who developed respiratory failure received the combined salbutamol-dexamethasone treatment. A potentiating effect of corticosteroids on the beta-adrenergic responsiveness is a possible explanation for the advantage of this combined treatment in the management of acute wheezing in infancy. The benefit of beta-adrenergic agonists in the treatment of acutely wheezing infants and young children has not been well documented in the outpatient setting. To determine the efficacy of nebulized metaproterenol sulfate, 74 children aged 36 months or younger with acute wheezing participated in a double-masked, randomized, placebo-controlled clinical trial. Children received nebulized metaproterenol, either as an initial treatment or after a control treatment with normal saline solution. At baseline and 20 minutes after each treatment, an assessment was made that included measurements of heart rate, respiratory rate, oxygen saturation, and clinical variables related to respiratory compromise with the use of a standardized respiratory distress index (RDI). Children who received saline solution as initial therapy had no significant differences from baseline in any of the assessment measures. After metaproterenol therapy, children demonstrated an increase in heart rate ([mean +/- SD] 147 +/- 14 beats per minute vs 153 +/- 16 beats per minute), a decrease in respirations (50/min +/- 5/min vs 45/min +/- 7/min), improvement (lower scores) on the RDI (24 +/- 4 vs 15 +/- 2), and an increase in oxygen saturation (94.1% +/- 2.7% vs 95.3% +/- 3.0%). Patients aged 12 months or younger (n = 37) benefited from metaproterenol treatment (improvement in respiratory rate and RDI) but not to the same degree as children aged 24 months or older (n = 23) (improvement in respiratory rate, RDI, and oxygen saturation). Compared with assessments made before metaproterenol treatment, patients with respiratory syncytial virus infection (n = 21) had improvement in respirations (52/min +/- 7/min vs 45/min +/- 6/min) and RDI scores (22 +/- 4 vs 14 +/- 3). Based on a priori criteria (reduction in a premedication respiratory rate of 20% and an RDI score of 50%), responders to metaproterenol therapy included 45% of the entire sample and, respectively, 40% of those aged 12 months or younger, 52% of those aged 24 months or older, and 48% of patients who tested positive for respiratory syncytial virus. Although there appears to be an age-dependent degree of response, metaproterenol is effective in relieving the respiratory distress of young acutely wheezing children, including those with documented respiratory syncytial virus bronchiolitis. A wide range of drugs are commonly used to treat bronchiolitis, but evidence of their effectiveness is limited.
                To investigate the efficacy of ipratropium bromide and salbutamol in the treatment of patients with moderate-severe bronchiolitis.
                Sixty-nine infants with moderate-severe bronchiolitis hospitalized at their first episode of wheezing or crepitations in the chest were enrolled in a prospective, double-blind, placebo-controlled trial. Patients were randomly assigned to receive nebulized salbutamol, ipratropium bromide or placebo. Main outcome measures were changes in oxygen saturation rates and clinical scores and duration of hospitalization.
                In the bronchodilator groups, clinical scores were better compared to the placebo group at 30 min (8.4 +/- 1.3 vs. 7.5 +/- 0.8, p < 0.05). Bronchodilator groups had also significantly lower clinical scores (7.3 +/- 1.2 vs. 5.9 +/- 1.1, p < 0.0001, and 5.3 +/- 1.4 vs. 4.5 +/- 1.6, p = 0.006, respectively) and higher oxygen saturation rates compared to the placebo group at 8 and 24 h (89.6 +/- 2.4 vs. 94.3 +/- 4.4, and 92.2 +/- 2.6 vs. 95.9 +/-4.4, respectively, p < 0.0001). Improvement rates and duration of hospitalization were not statistically different among groups.
                Clinical scores and oxygen saturation levels improved more rapidly in the bronchodilator groups than in the placebo group up to 24 h, but these drugs did not have a sufficient effect to change the natural course of the disease.
                Copyright 2007 S. Karger AG, Basel. The main purpose of this study was to evaluate four different forms of treatment in young infants admitted for acute wheezing (AW). Seventy-nine infants less than one year of age were randomly assigned to one of five groups. Group 1 received nebulized fenoterol plus ipratropium bromide, group 2 fenoterol, group 3 fenoterol plus steroids, and group 4 aminophylline, IV, plus steroids and oral fenoterol; the control group, or group 5, received nebulized normal saline solution. Clinical evaluation was done by means of a scoring system. The effectiveness of treatments was estimated by a score decrease in the first 24 hours, by the percentage of patients whose scores did not decrease during the same period, and by the number of days in the hospital. All infants had significantly decreased scores, except those in the control group; the aminophylline group included a greater percentage of patients who did not abate their scores, and they stayed in the hospital for more days than those in the other groups. The fenoterol group had the shortest hospital stay. All four treatments produced objective clinical improvement in bronchial obstruction. However, the nebulized bronchodilator treatments were more effective than aminophylline IV in decreasing scores on the first day, and they resulted in shorter hospitalization. To determine the efficacy of oral salbutamol for providing symptomatic relief in mild bronchiolitis.
                Randomized double-blind placebo controlled trial.
                Pediatric Outpatient Department of a tertiary care hospital.
                140 infants (of 310 approached) with a clinical diagnosis of acute bronchiolitis with respiratory rate <or= 70 breath/min, heart rate <or= 200 beats/min, hemoglobin oxygen saturation (SpO2) >or= 95% in room air, no or mild accessory muscle use, and respiratory distress assessment instrument (RDAI) score <or=10. Children were followed up for 14 days.
                Oral salbutamol (0.1 mg/kg/dose) (n=70) or placebo (n=70) three times a day for 7 days or till complete resolution of symptoms,whichever was earlier.
                Time for resolution of illness (ROI), duration of fever, cough,coryza, noisy breathing, time to achieve normal feeding and normal sleep, and frequency of hospitalization and adverse effects.
                Median (SE, 95% CI) duration of resolution of overall illness was similar in the two groups [6 (0, 5 to 7) d in the salbutamol group vs. 5 (1, 4 to 6) days in placebo group; P=0.21]. There was no significant difference in mean duration of fever, cough, coryza, noisy breathing, time to achieve normal feeding and normal sleep; and frequency of hospitalization or adverse effects, between the two groups.However, tremors were observed in 5 infants in the salbutamol group.
                Oral salbutamol is not superior to placebo in reducing the duration of symptoms in mild cases of acute bronchiolitis in children. In a double-blind, placebo-controlled trial, 40 infants between 6 weeks and 24 months of age who had a first episode of wheezing and other signs and symptoms of bronchiolitis were randomly assigned to receive either nebulized albuterol (0.15 mg/kg/dose) or placebo (saline solution) for two administrations 1 hour apart. The albuterol therapy resulted in a significantly greater improvement in the accessory muscle score (decreases 0.70 vs decreases 0.30; p = 0.03), oxygen saturation (increases 0.71% vs decreases 0.47%; p = 0.01) after one dose, and in the accessory muscle score (decreases 0.86 vs decreases 0.37; p = 0.02), respiratory rate (decreases 19.6% vs decreases 8.0%; p = 0.016), and oxygen saturation (increases 0.76% vs decreases 0.79%; p = 0.015) after two doses of the drug. The response to therapy was similar in infants younger and those older than 6 months of age. The heart rate rose slightly more in the albuterol group (increases 7.76 from baseline) versus the placebo group (decreases 6.79). There were no other side effects of the treatment. Of the 34 children from whom nasal specimens were obtained by swab for viral identification, 24 had positive test results (21 for respiratory syncytial virus, 1 for parainfluenza, 1 for paramyxovirus, and 1 for influenza A). We conclude that nebulized albuterol constitutes a safe and effective treatment of infants with bronchiolitis. To determine whether oral albuterol is effective in reducing symptomatology of acute viral bronchiolitis in infants with mild-to-moderate illness.
                In a randomized, double-blind trial, previously well infants were randomized upon discharge from the emergency department to receive either albuterol (0.1 mg/kg/dose) three times per day or placebo three times per day for 7 days. Daily standardized telephone interviews were conducted for as long as 14 days. The primary outcome was the time to resolution of illness. Secondary outcomes included time to normal feeding, normal sleeping, quiet breathing, resolved cough, and coryza.
                We studied 129 infants (albuterol, n = 64; placebo, n = 65). Baseline characteristics were similar between groups. The overall mean age was 5.3 months, 60% were male, and 49 of 61 tested infants were positive for respiratory syncytial virus. The median (95% confidence interval) time to resolution of illness (days) was similar: albuterol, 9.0 (8-13); placebo, 8.0 (7-9); P =.3) (log-rank test). There were no significant group differences in any secondary outcome. Health care revisit and admission rates were similar between groups.
                No significant group differences in either primary or secondary outcomes in infants treated with oral albuterol versus placebo were found. The widespread use of oral albuterol in this patient group is not recommended. In previously well infants hospitalized with acute viral bronchiolitis, the effectiveness of repeated nebulized therapy with epinephrine (EPI) was compared with treatment with albuterol (ALB) or saline placebo (PLAC).
                In this randomized, double-blind, parallel-group, controlled trial, infants received study nebulizations every 1 to 6 hours and were assessed twice daily by the research team. The primary outcome was length of hospital stay (LOS). Secondary outcomes included the time from admission until the infant had normal hydration, oxygenation, and minimal respiratory distress.
                A total of 149 infants were randomized; 50 were allocated to receive racemic EPI, 51 were given ALB, and 48 received PLAC. Baseline characteristics and pre-enrollment symptoms, signs, and therapy were similar between groups. There were no group differences in the primary outcome measure, mean LOS (hours)(+/- SD): EPI = 59.8 (62), ALB = 61.4 (54), and PLAC = 63.3 (47); P =.95 by intent-to-treat analysis. Group differences were not statistically significant in any of the secondary outcomes.
                There were no group differences in the effectiveness of therapy for infants hospitalized with bronchiolitis. Based on these results, we do not recommend routine use of either nebulized EPI or ALB in this patient group. In a double blind randomised trial, we found no evidence that nebulised ipratropium bromide was of clinical benefit in acute bronchiolitis. The role of bronchodilators in the treatment of bronchiolitis remains controversial.
                A double-blind, placebo controlled trial was performed to evaluate the clinical response to nebulized salbutamol. One hundred and fifty-six infants aged between 7 weeks and 24 months who had had an episode of wheezing and other signs and symptoms of bronchiolitis were randomized to three groups as follows: (i) nebulized salbutamol was administered to 52 patients in group I at a dose of 0.15 mg/kg in 2 mL saline; (ii) saline was nebulized to 52 patients in group II and (iii) in group III 52 patients received mist in a tent. All three groups were administered oxygen during the procedures. Treatment was repeated with the same agent after 30 min if the respiratory score was 5 or more. Respiratory rate, heart rate, oxygen saturation and presence of cyanosis, wheezing, retractions were recorded before and after each treatment.
                The decrease in the respiratory score was 5.2 +/- 1.8, 0.82 +/- 2.4 and 1.7 +/- 1.3 in group I, II and III, respectively. The decrease in group I was significantly higher than in the other groups. Heart rate was similar between groups. Oxygen saturation decreased in group I without reaching statistical significance.
                Salbutamol was shown to be effective and safe in the treatment of acute bronchiolitis. The objective of this study was to investigate the effectivenesses of nebulized salbutamol, epinephrin, 3% saline, and normal saline (0.9% NaCl) in the treatment of mildly affected infants with acute bronchiolitis. We enrolled 186 children (mean age 9.5 +/- 5.3 months, range 1.5-24 months, 65.1% male) with a first episode of wheezing diagnosed as mild bronchiolitis in emergency department. Patients were randomized in a double-blind fashion to receive 4 ml dose either of 1.5 mg epinephrine plus normal saline (group 1; n = 38) or 1.5 mg epinephrine plus 3% saline (group 2; n = 39) or 2.5 mg salbutamol plus normal saline (group 3; n = 36) or 2.5 mg salbutamol plus 3% saline (group 4; n = 36) or normal saline alone (group 5; n = 37) at 0 and 30 min. Thus, all treatment modalities included high amount of NaCl (72-240 mg). Clinical score, oxygen saturation and heart rate were assessed at 0, 30, 60, and 120 min. After discharge, patients were reassessed by telephone contact at 48 hr and 6 months. The baseline characteristics were similar in all groups (P > 0.05). The outcome of patients at 120 min was found significantly better than the baseline values (P < 0.05). There were no significant differences between the outcome variables of the groups (P > 0.05). No adverse effects attributable to nebulized therapy were seen. In conclusion, all treatment modalities used in this study, including a total of 8 ml normal saline inhalation at 30-min interval showed clinically significant and swift improvement in mildly affected ambulatory infants with acute bronchiolitis.
                (c) 2009 Wiley-Liss, Inc. Using a double-blind, placebo-controlled protocol, we evaluated the efficacy of nebulized albuterol in the treatment of infants aged 0 to 24 months who presented to the emergency department with wheezing. Twenty-five infants were randomly assigned to receive two identical treatments of either nebulized albuterol (0.15 mg/kg) or placebo (saline). Assessment after each treatment included a wheeze and retraction score, respiratory and heart rates, and pulse oximetry. After two treatments, there was a significant improvement in the wheeze scores (P less than 0.05) and total scores (P less than 0.05) of the albuterol group compared with the placebo group. After one treatment, there was an initial decrease in oxygen saturation in the albuterol group, which improved after the second treatment. There were no significant differences between the two groups in heart rate or respiratory rate. This study supports the use of nebulized albuterol in the treatment of wheezing infants in the emergency department. Our objective was to determine if nebulized racemic epinephrine is more efficacious than nebulized albuterol or saline placebo in the treatment of bronchiolitis in the outpatient setting when dosing is equivalent in terms of beta-2 agonist potency. Sixty-five patients between ages 6 weeks and 24 months with a diagnosis of bronchiolitis, defined as first-time wheezing, upper respiratory symptoms and/or fever, and a Respiratory Distress Assessment Instrument score of at least 4, were randomized to receive 5 mg nebulized albuterol, 5 mg nebulized racemic epinephrine, or an equivalent volume of placebo at 0, 30, and 60 min. The primary outcome measure was need for hospital admission or home oxygen. Secondary outcome measures were changes in clinical scores and oxygen saturations. There were no significant statistical differences between groups in terms of need for hospital admission or outpatient management with home oxygen therapy. There were no differences between groups in terms of changes in clinical scores or oxygen saturations. Racemic epinephrine and albuterol at equivalent doses had no effect on the need for hospitalization or supplemental oxygen in bronchiolitis in the outpatient setting compared to nebulized saline placebo, though this study may have missed less dramatic clinical effects due to small sample size.
                2005 Wiley-Liss, Inc. To evaluate the effect of nebulized albuterol on tidal breathing flow-volume loops in infants with bronchiolitis due to respiratory syncytial virus.
                A randomized, double-blind, control study.
                Pediatric unit in a community teaching hospital.
                Twenty infants younger than 1 year of age (mean age, 5.8 +/- 2.8 months) with a first episode of wheezing due to respiratory syncytial virus bronchiolitis.
                Chloral hydrate (50 mg/kg) was administered orally for sedation. One dose each of nebulized albuterol (0.15 mg/kg in 3 ml saline) and saline (3 ml) were given at 6 hour intervals in a random order.
                Tidal breathing flow-volume loops were obtained before and after each aerosol treatment with a Neonatal/Pediatric Pulmonary Testing System (Model 2600; Sensor Medics, Anaheim, CA, USA). At the same time, the fraction of tidal volume exhaled at peak tidal expiratory flow (PTEF) to total tidal volume (VPTEF/VE), and the fraction of exhaled time at PTEF to total expiratory time (tPTEF/tE) were measured. The PTEF, the tidal expiratory flows at 10%, 25%, and 50% of the remaining tidal volume (TEF10, TEF25, and TEF50), and the wheeze score were also determined.
                There were no significant changes in VPTEF/VE and tPTEF/tE after albuterol or saline treatment. PTEF increased significantly both after albuterol and saline treatments but the difference between the two treatments was not significant (P = 0.6). Both TEF10 and the ratio of the tidal expiratory flow at 25% of the remaining tidal volume to PTEF (25/PT) decreased significantly (P < 0.05) after administration of albuterol. All other investigated variables were not significantly affected by aerosol administration.
                Nebulized albuterol in infants with mild bronchiolitis due to respiratory syncytial virus did not improve VPTEF/VE and tPTEF/tE but did decrease TEF10 and 25/PT. To determine whether the use of albuterol by nebulization enhances physiologic or clinical recovery in hospitalized infants with moderate bronchiolitis.
                This prospective, double-blind, placebo-controlled, randomized clinical trial was performed from December 1995 to March 1996. A total of 52 patients <24 months of age with a diagnosis of moderately severe, acute viral bronchiolitis were enrolled and assigned to receive nebulized albuterol or normal saline placebo for 72 hours under a standardized protocol. Primary outcome measures included improvement in oxygen saturation (SaO2) during hospitalization and survival analysis to assess the time required to reach preestablished discharge criteria on three measures: SaO2, accessory muscle use, and wheezing. An additional secondary outcome measure was actual length of hospital stay. Adverse outcomes also were compared between treatment groups.
                There was no significant difference in mean SaO2 between albuterol and placebo at baseline, 24 hours, or maximum SaO2 achieved during hospitalization. Both groups showed significant improvement in oxygen saturation over time, but there was no significant difference in improvement between the two groups. The study had a power of 90% to detect a difference in mean percentage point improvement of 2% SaO2. There was no difference in time to reach discharge criteria as defined by SaO2, accessory muscle use, or wheezing. There was no difference in length of hospital stay or in the frequency of adverse outcomes.
                Nebulized albuterol therapy does not appear to enhance recovery or attenuate severity of illness in infants hospitalized with acute, moderate bronchiolitis, as evidenced by improvement in oxygen saturation, time to meet standardized discharge criteria, or length of hospital stay. Bronchiolitis is a common respiratory infection affecting young children. Much controversy revolves around the efficacy of bronchodilators in the treatment of bronchiolitis. This study was conducted to address this issue.
                To determine the efficacy of bronchodilators in the treatment of bronchiolitis.
                All children less than 2 years old with bronchiolitis were randomly assigned to receive nebulisations of Salbutamol, Ipratropium bromide or normal saline. A fourth group given only humidified oxygen without nebulisation were used as a control.
                Data were obtained for 120 patients. Fifty-one (42%) had respiratory syncytial virus (RSV) isolated from their nasopharyngeal aspirates. The demographic characteristics of the 4 groups were similar. There was no significant difference between the groups in terms of severity score, number of nebulisations required in the nebulised groups and the outcome as measured by the length of hospitalisation.
                The use of bronchodilators did not alter the course of the disease and is therefore not effective in the treatment of bronchiolitis. A randomised double blind trial was conducted to determine the efficacy of inhaled bronchodilators, salbutamol and ipratropium bromide, compared with placebo in the treatment of bronchiolitis. Patients, who were 2 months to 2 years of age and without underlying cardiac or pulmonary disease, received drug 1 (salbutamol or saline placebo) followed one hour later by drug 2 (ipratropium bromide or placebo). Both agents were administered every four hours. The patients were allocated to one of four groups according to a factorial design. The four groups were similar in demographic characteristics, initial oxygenation, and clinical score. The change in oxygen saturation of recipients of both agents was significantly better than that of recipients of salbutamol alone or ipratropium bromide alone. This change, however, was not statistically different from that of the control group. No difference was observed in the clinical score or hospital duration. Inhaled bronchodilators did not improve the condition of hospitalised mild bronchiolitis. Inhaled sympathomimetic agents are often used in bronchiolitis with little objective evidence of benefit. The arterial oxygen saturation (SaO2) reflects the adequacy of ventilation-perfusion balance. The aim of the current study was to determine the effect of inhaled salbutamol on SaO2. In a randomised, double blind study, 21 infants, admitted with bronchiolitis positive for respiratory syncytial virus, had continuous SaO2 measurements made before and after nebulised salbutamol or placebo. SaO2 was recorded over 30 minutes for a baseline, then during the 10 minutes of first nebulisation with either salbutamol or saline, then over 30 minutes after nebulisation, the 10 minutes of second nebulisation with the alternate regime, and another 30 minutes after this second nebulisation. Desaturation occurred after salbutamol and saline nebulisation. The fall in SaO2 with salbutamol was seen whether infants received it as the first or second nebulisation. The fall in SaO2 after saline was seen when given first, but not when given after salbutamol. The decrease in SaO2 was greater and more prolonged with salbutamol than with saline. Routine nebulised aerosol sympathomimetic treatment during acute bronchiolitis cannot be recommended. To test whether nebulized salbutamol (albuterol) is safe and efficacious for the treatment of young children with acute bronchiolitis, we enrolled 83 children (median age 6 months, range 1 to 21 months) in a randomized, double-blind clinical trial. Participants received two treatments at 30-minute intervals of either nebulized salbutamol (0.10 mg/kg in 2 ml 0.9% saline solution) or a similar volume of 0.9% saline solution placebo. Outcome measures were the respiratory rate, pulse oximetry, and a clinical score based on the degree of wheezing and retractions. Patients in the salbutamol arm had significantly greater improvement in clinical scores after the initial treatment (p = 0.04). There was no difference between the groups in oxygen saturation (p = 0.74); patients treated with salbutamol had a small increase in heart rate after two treatments (159 +/- 16 vs 151 +/- 16; p = 0.03). We conclude that salbutamol is safe and effective for the initial treatment of young children with acute bronchiolitis. To study patients with respiratory syncytial virus bronchiolitis in respiratory failure to make specific measurements reflecting airway resistance before and after treatment with commonly used agents. We hypothesized that racemic epinephrine would decrease airways resistance more effectively than levalbuterol, and levalbuterol would decrease airways resistance more effectively than racemic albuterol. Normal saline was used as a control.
                Prospective, randomized, controlled, blinded study.
                Tertiary Pediatric Intensive Care Unit in a University affiliated hospital in the northeastern United States.
                Twenty-two patients with respiratory syncytial virus bronchiolitis and in respiratory failure were enrolled. All were intubated and ventilated in a volume control mode and sedated.
                In a randomized, blinded fashion patients were given four agents: norepinephrine, levalbuterol, racemic albuterol, and normal saline at 6 hr intervals.
                As indicators of bronchodilation, peak inspiratory pressure and inspiratory respiratory system resistance were measured before and 20 mins after each agent was given. Thus, each patient acted as his/her own control.
                There were small but statistically significant decreases in peak inspiratory pressure after racemic epinephrine treatment, levalbuterol, and racemic albuterol. There was no change in peak inspiratory pressure after inhaled normal saline. Inspiratory respiratory system resistance fell significantly after all treatments, including saline. Heart rate rose significantly after inhaled bronchodilator treatments (p < 0.05 for all treatments).
                Similar statistically significant bronchodilation occurred after all three bronchodilators as indicated by a decrease in peak inspiratory pressure and respiratory system resistance, but these changes were small and probably clinically insignificant. However, side effects of bronchodilators, such as tachycardia, also occurred, and these may be clinically significant. Thus the benefit of bronchodilator treatment in these patients is small, does not differ among the drugs we studied and of questionable value. A randomized clinical trial was conducted on young children with bronchiolitis admitted to hospital with moderate illness to determine the efficacy of the bronchodilators Salbutamol and ipratropium bromide, either as a single drug or in combination, given as a nebulized solution, compared with a normal saline placebo. Eighty-nine patients, aged from 23 days to 11 months, were randomized into four groups, depending on administered drug or placebo, as follows: group 1--Salbutamol (n = 20); group 2--ipratropium bromide (n = 23); group 3--combined Salbutamol and Ipratropium bromide (n = 24); group 4--normal saline (n = 22). The groups were identical with respect to age, sex, family history of atopy, respiratory syncytial virus (RSV) positivity and enrollment score. They were scored using the clinical parameters of wheezing, retractions and respiratory rate at enrollment, at 30 and 60 minutes after the first nebulization, and after 60 minutes following completion of subsequent nebulization at 6, 12, 24 and 36 hours. We did not find any significant difference in the rate of improvement and the final score (p = 0.49) in the four groups. The same finding was also noted in children aged more than 3 months (p = 0.35) and in those positive for RSV infection (p = 0.18). The lengths of hospitalization in the four groups were also similar (p = 0.79). It is concluded that there is no role for the nebulized bronchodilators Salbutamol and Ipratropium bromide, either as a single agent or in combination, compared with normal saline placebo in treating young children in hospital with bronchiolitis. To examine the efficacy of albuterol (0.15 mg/kg per dose) in the management of bronchiolitis.
                Randomized, double-blind, placebo-controlled outpatient clinical trial utilizing four study groups: neubulized albuterol, nebulized saline, oral albuterol, and oral placebo.
                Pediatric emergency department and outpatient clinic at University of Maryland in Baltimore.
                Eighty-eight infants (median age 5.5 months) being treated for their first episode of wheezing were randomly assigned to nebulized albuterol (n = 22), nebulized saline (n = 23), oral albuterol (n = 19), oral placebo (n = 24).
                The nebulized groups received two nebulizations 30 minutes apart, whereas the oral groups received one oral dose.
                Respiratory and heart rates, clinical score, oxygen saturation (Spo2), and the infant's state, ie, asleep, awake, or feeding, were recorded at baseline and at 30 and 60 minutes after treatment.
                Randomization produced equivalent groups in terms of demographics and baseline measures. There were no statistically significant differences in any outcomes among the four treatments, except for oral albuterol, which produced an increase in heart rate (15 beats per minute, P = .005). No differences in the need for additional treatment or hospitalization were observed. Change in the state of the infant during the trial had significant effects on respiratory rate and clinical score.
                Albuterol is as effective as oral placebo in the management of bronchiolitis. Past studies supporting the use of albuterol did not control for effects of change in state of the infant and did not use a truly inactive placebo group. This study underscores the importance of these design components in measuring the efficacy of albuterol in infants. The efficacy of albuterol in the management of infants with first-time wheezing is controversial. This double-blind, placebo-controlled trial involved 128 Egyptian infants with first-time wheezing (mean age 5.9 months) who were randomly separated into four equivalent therapy groups: nebulized albuterol, nebulized saline solution, orally administered albuterol, and orally administered placebo. The nebulized therapy groups received two treatments 30 minutes apart; the oral therapy groups received one treatment. In addition, 41 infants with recurrent wheezing comprised an open-label control group who received two albuterol nebulizations. Chest radiographs, leukocyte counts, blood culture specimens, and nasal aspirate for viral antigen detection were obtained to confirm the clinical diagnosis of viral bronchiolitis. Respiratory and heart rates, clinical score, and oxygen saturation were recorded at baseline and 30 and 60 minutes after treatment. There was no difference among the four randomized groups in any of the outcomes except for an increase in heart rate of 10 beats/min in the nebulized albuterol group compared with a decrease in heart rate of 8 beats/min in the oral placebo group. No differences in the need for additional treatment were observed. Nebulized albuterol significantly improved the clinical score and reduced the respiratory rate of those with recurrent wheezing relative to those in the randomized groups. We conclude that nebulized albuterol is effective in the treatment of infants with recurrent wheezing, but there was no demonstrable efficacy of orally administered or nebulized albuterol in relieving the respiratory distress of infants with bronchiolitis in Egypt.