Oral salbutamol for symptomatic relief in mild bronchiolitis a double blind randomized placebo controlled trial.

ABSTRACT

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.