Randomized controlled trial of ipratropium bromide and frequent low doses of salbutamol in the management of mild and moderate acute pediatric asthma.

Abstract

To compare the effectiveness and safety of alternative nebulized drug protocols in children with mild or moderate asthma exacerbations. We conducted a blinded, randomized, controlled trial with a 2 x 2 factorial design. Two interventions, nebulized salbutamol in frequent low doses (0.075 mg/kg every 30 minutes) and the addition of ipratropium bromide (250 micrograms), were compared with salbutamol in hourly high doses (0.15 mg/kg every 60 minutes) in children with mild or moderate acute asthma. The primary end point was the improvement in respiratory resistance. Secondary end points included oxygen saturation, corticosteroid use, patient disposition, and relapse status. A total of 298 participants aged 3 to 17 years were studied, and 15% were admitted to the hospital; 14% of the children had relapses. No increased bronchodilation was associated with frequent low doses versus hourly high doses of salbutamol (RR = 0.9 [95% confidence interval 0.7, 1.3]) or the addition of ipratropium bromide versus placebo (RR = 1.0 [0.8, 1.3]). No group differences were observed in secondary end points. Salbutamol in frequent low doses was associated with increased vomiting (RR = 2.5 [1.1, 6.0]). Our results do not support the use of frequent low doses of nebulized salbutamol or the addition of ipratropium bromide compared with hourly high doses of salbutamol in children with mild or moderate asthma.