BACKGROUND: Although recent evidence has strongly supported the use of glucocorticoid therapy in children hospitalized with croup, the benefit of this therapy in children with less severe croup has not been documented. This randomized, double-blind trial compared a nebulized glucocorticoid, budesonide, with placebo in outpatients with mild-to-moderate croup. METHODS:Children three months to five years of age were eligible for the study if their croup scores fell in the mild-to-moderate range (scores of 2 to 7 out of a possible 17). The patients were randomly assigned to receive either 2 mg (4 ml) of nebulized budesonide (27 children) or 4 ml of nebulized normal saline (27 children); they were then assessed hourly for up to four hours by investigators who were unaware of the assigned treatments. RESULTS: The median croup score at entry into the study was 4 in both groups. At the final study assessment, the median score was significantly lower in the budesonide group than in the placebo group (1 vs. 3, P = 0.005). The patients in the budesonide group were discharged from the emergency department significantly earlier than those in the placebo group (P = 0.002). One week after enrollment, 21 patients assigned to placebo had received dexamethasone, as compared with 15 patients assigned to budesonide (P = 0.10), and 7 patients assigned to placebo had been admitted to the hospital, as compared with 1 patient assigned to budesonide (P = 0.05). CONCLUSIONS: We conclude that nebulized budesonide leads to a prompt and important clinical improvement in children with mild-to-moderate croup who come to the emergency department.
RCT Entities:
BACKGROUND: Although recent evidence has strongly supported the use of glucocorticoid therapy in children hospitalized with croup, the benefit of this therapy in children with less severe croup has not been documented. This randomized, double-blind trial compared a nebulized glucocorticoid, budesonide, with placebo in outpatients with mild-to-moderate croup. METHODS:Children three months to five years of age were eligible for the study if their croup scores fell in the mild-to-moderate range (scores of 2 to 7 out of a possible 17). The patients were randomly assigned to receive either 2 mg (4 ml) of nebulized budesonide (27 children) or 4 ml of nebulized normal saline (27 children); they were then assessed hourly for up to four hours by investigators who were unaware of the assigned treatments. RESULTS: The median croup score at entry into the study was 4 in both groups. At the final study assessment, the median score was significantly lower in the budesonide group than in the placebo group (1 vs. 3, P = 0.005). The patients in the budesonide group were discharged from the emergency department significantly earlier than those in the placebo group (P = 0.002). One week after enrollment, 21 patients assigned to placebo had received dexamethasone, as compared with 15 patients assigned to budesonide (P = 0.10), and 7 patients assigned to placebo had been admitted to the hospital, as compared with 1 patient assigned to budesonide (P = 0.05). CONCLUSIONS: We conclude that nebulized budesonide leads to a prompt and important clinical improvement in children with mild-to-moderate croup who come to the emergency department.