OBJECTIVE: To examine the efficacy of albuterol (0.15 mg/kg per dose) in the management of bronchiolitis. DESIGN: Randomized, double-blind, placebo-controlled outpatient clinical trial utilizing four study groups: neubulized albuterol, nebulized saline, oral albuterol, and oral placebo. SETTING:Pediatric emergency department and outpatient clinic at University of Maryland in Baltimore. PATIENTS: 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). INTERVENTIONS: The nebulized groups received two nebulizations 30 minutes apart, whereas the oral groups received one oral dose. MAIN OUTCOME MEASURES: 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. RESULTS: 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. CONCLUSIONS: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.
RCT Entities:
OBJECTIVE: To examine the efficacy of albuterol (0.15 mg/kg per dose) in the management of bronchiolitis. DESIGN: Randomized, double-blind, placebo-controlled outpatient clinical trial utilizing four study groups: neubulized albuterol, nebulized saline, oral albuterol, and oral placebo. SETTING: Pediatric emergency department and outpatient clinic at University of Maryland in Baltimore. PATIENTS: 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). INTERVENTIONS: The nebulized groups received two nebulizations 30 minutes apart, whereas the oral groups received one oral dose. MAIN OUTCOME MEASURES: 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. RESULTS: 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. CONCLUSIONS: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.
Authors: Scott A Lorch; Michael Baiocchi; Jeffrey H Silber; Orit Even-Shoshan; Gabriel J Escobar; Dylan S Small Journal: Health Serv Res Date: 2009-09-24 Impact factor: 3.402