AIM: To determine the efficacy of adding ipratropium bromide to nebulized salbutamol in the treatment of children with moderate-to-severe acute asthma attacks. METHODS: A total of 102 patients aged between 5 months and 16 years were included in a double-blind randomized trial. All patients were given nebulized salbutamol (0.2 mg/kg) and oral steroids (1 mg/kg). Patients in group A received two doses of nebulized ipratropium bromide (250 mg per dose) and patients in group B were given placebo. Oxygen saturation (SaO2) and a clinical score (heart rate, respiratory rate, dyspnea, retraction of the intercostal spaces, and wheezing) rated from 0 to 5 were measured before treatment and at 120 min. RESULTS: Patients in both groups showed similar SaO2 values and clinical scores at baseline (group A, 93.05% and 4.45; group B, 92.78% and 4.43) and at 120 min (group A, 94.33% and 2.45; group B, 94.03% and 2.74), but the percentage of patients admitted to the hospital was higher in group B than in group A (53% vs 35%, p = 0.07). In the subset of patients with the most severe attacks (baseline score 5), the clinical score after treatment and the percentage of admissions were significantly higher in group B (n = 22) than in group A (n = 23) (3.32 vs 2.69 and 73% vs 39%, p < 0.05). CONCLUSIONS: Coadministration of ipratropium bromide and repeat doses of nebulized salbutamol produced a small beneficial clinical effect compared with administration of nebulized salbutamol alone. This beneficial effect was related to a decrease in the hospitalization rate, particularly in patients with severe asthma attacks.
RCT Entities:
AIM: To determine the efficacy of adding ipratropium bromide to nebulized salbutamol in the treatment of children with moderate-to-severe acute asthma attacks. METHODS: A total of 102 patients aged between 5 months and 16 years were included in a double-blind randomized trial. All patients were given nebulized salbutamol (0.2 mg/kg) and oral steroids (1 mg/kg). Patients in group A received two doses of nebulized ipratropium bromide (250 mg per dose) and patients in group B were given placebo. Oxygen saturation (SaO2) and a clinical score (heart rate, respiratory rate, dyspnea, retraction of the intercostal spaces, and wheezing) rated from 0 to 5 were measured before treatment and at 120 min. RESULTS:Patients in both groups showed similar SaO2 values and clinical scores at baseline (group A, 93.05% and 4.45; group B, 92.78% and 4.43) and at 120 min (group A, 94.33% and 2.45; group B, 94.03% and 2.74), but the percentage of patients admitted to the hospital was higher in group B than in group A (53% vs 35%, p = 0.07). In the subset of patients with the most severe attacks (baseline score 5), the clinical score after treatment and the percentage of admissions were significantly higher in group B (n = 22) than in group A (n = 23) (3.32 vs 2.69 and 73% vs 39%, p < 0.05). CONCLUSIONS: Coadministration of ipratropium bromide and repeat doses of nebulized salbutamol produced a small beneficial clinical effect compared with administration of nebulized salbutamol alone. This beneficial effect was related to a decrease in the hospitalization rate, particularly in patients with severe asthma attacks.