Background Although recent evidence has strongly supported theuse of glucocorticoid therapy in children hospitalized withcroup, the benefit of this therapy in children with less severecroup has not been documented. This randomized, double-blindtrial compared a nebulized glucocorticoid, budesonide, withplacebo in outpatients with mild-to-moderate croup.
Methods Children three months to five years of age were eligiblefor the study if their croup scores fell in the mild-to-moderaterange (scores of 2 to 7 out of a possible 17). The patientswere randomly assigned to receive either 2 mg (4 ml) of nebulizedbudesonide (27 children) or 4 ml of nebulized normal saline(27 children); they were then assessed hourly for up to fourhours by investigators who were unaware of the assigned treatments.
Results The median croup score at entry into the study was 4in both groups. At the final study assessment, the median scorewas significantly lower in the budesonide group than in theplacebo group (1 vs. 3, P = 0.005). The patients in the budesonidegroup were discharged from the emergency department significantlyearlier than those in the placebo group (P = 0.002). One weekafter enrollment, 21 patients assigned to placebo had receiveddexamethasone, as compared with 15 patients assigned to budesonide(P = 0.10), and 7 patients assigned to placebo had been admittedto the hospital, as compared with 1 patient assigned to budesonide(P = 0.05).
Conclusions We conclude that nebulized budesonide leads to aprompt and important clinical improvement in children with mild-to-moderatecroup who come to the emergency department.
Source Information
From the Department of Pediatrics, University of Ottawa, Ottawa, Ont. (T.P.K., L.K.W., T.S.); Scarborough Grace Hospital, Scarborough, Ont. (M.E.F.); and the Department of Pediatrics, Johns Hopkins University, Baltimore (P.C.R.).
Address reprint requests to Dr. Rowe at the Department of Pediatrics, Johns Hopkins Hospital, 600 N. Wolfe St./Brady 212, Baltimore, MD 21287.
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