THE EFFICACY OF NEBULIZED BUDESONIDE IN DEXAMETHASONE-TREATED OUTPATIENTS WITH GROUP

Objective. To determine the added clinical benefit of nebulized budeso nide in children with mild to moderate croup treated with 0.6 mg/kg or al dexamethasone. Design. Randomized, double-blind, placebo-controlled trial. Setting. Emergency department of a tertiary-care pediatric hos pital with 47 000 visits per year. Participants. Children 3 months to 5 years of age with a syndrome consisting of hoarseness, inspiratory s trider, and barking cough and a croup score of 3 or greater after at l east 15 minutes of mist therapy. Patients were excluded from the study if they had diagnoses of epiglottitis, chronic upper or lower airway disease (not including asthma), or severe croup or had received cortic osteroids within the preceding 2 weeks. Intervention. All patients rec eived 0.6 mg/kg oral dexamethasone and were randomly assigned to recei ve 4 mL (2 mg) of budesonide solution (n = 25) or 4 mL of 0.9% saline solution (n = 25) by updraft nebulizer with a continuous flow of oxyge n at 5 to 6 L/min. Main Outcome Measures. The primary outcome measure was the proportion of patients in each group who had clinically import ant changes (two points) in the croup score during the 5 hours after t reatment. Results. Eighty-four percent (n = 21) of the patients who re ceived budesonide had clinically important responses, compared with 56 % (n = 14) in the placebo group. The number of patients who would need to be treated with nebulized budesonide for one patient to have a cli nically important response is four patients. Conclusions. Despite rece iving simultaneous oral dexamethasone, pediatric outpatients with mild to moderate croup have added, clinically important improvement in res piratory symptoms after treatment with budesonide.