Oral salbutamol for symptomatic relief in mild bronchiolitis a double blind randomized placebo controlled trial.
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2008-07-13
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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.
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Gupta P, Aggarwal A, Gupta P, Sharma KK. Oral salbutamol for symptomatic relief in mild bronchiolitis a double blind randomized placebo controlled trial. Indian Pediatrics. 2008 Jul; 45(7): 547-53