NEBULIZED BUDESONIDE FOR CHILDREN WITH MILD-TO-MODERATE CROUP

Background. Although recent evidence has strongly supported the use of glucocorticoid therapy in children hospitalized with croup, the benef it of this therapy in children with less severe croup has not been doc umented. This randomized, double-blind trial compared a nebulized gluc ocorticoid, budesonide, with placebo in outpatients with mild-to-moder ate croup. Methods. Children three months to five years of age were el igible for the study if their croup scores fell in the mild-to-moderat e range (scores of 2 to 7 out of a possible 17). The patients were ran domly assigned to receive either 2 mg (4 ml) of nebulized budesonide ( 27 children) or 4 ml of nebulized normal saline (27 children); they we re then assessed hourly for up to four hours by investigators who were unaware of the assigned treatments. Results. The median croup score a t entry into the study was 4 in both groups. At the final study assess ment, 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 b udesonide group were discharged from the emergency department signific antly earlier than those in the placebo group (P = 0.002). One week af ter enrollment, 21 patients assigned to placebo had received dexametha sone, 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). Conclusi ons. We conclude that nebulized budesonide leads to a prompt and impor tant clinical improvement in children with mild-to-moderate croup who come to the emergency department.