OBJECTIVES: To determine the efficacy of oral salbutamol for providing symptomatic relief in mild bronchiolitis. DESIGN: Randomized double-blind placebo controlled trial. SETTING:Pediatric Outpatient Department of a tertiary care hospital. SUBJECTS: 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. INTERVENTION: 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. OUTCOME VARIABLES: 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. RESULTS: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. CONCLUSION:Oral salbutamol is not superior to placebo in reducing the duration of symptoms in mild cases of acute bronchiolitis in children.
RCT Entities:
OBJECTIVES: To determine the efficacy of oral salbutamol for providing symptomatic relief in mild bronchiolitis. DESIGN: Randomized double-blind placebo controlled trial. SETTING: Pediatric Outpatient Department of a tertiary care hospital. SUBJECTS: 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. INTERVENTION: 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. OUTCOME VARIABLES: 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. RESULTS: 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. CONCLUSION: Oral salbutamol is not superior to placebo in reducing the duration of symptoms in mild cases of acute bronchiolitis in children.
Authors: V Oktaria; K J Lee; J E Bines; E Watts; C D Satria; J Atthobari; H Nirwati; C D Kirkwood; Y Soenarto; M H Danchin Journal: BMC Pediatr Date: 2017-12-21 Impact factor: 2.125