Comparison between single-dose oral prednisolone and oral dexamethasone in the treatment of croup: A randomized, double-blinded clinical trial

Objective: To compare the effectiveness of three corticosteroid regimens in children with mild to moderate croup. Methods: Double-blinded, randomized comparative trial with parallel design, conducted in the ED of a paediatric tertiary care hospital. Children aged 6 months to 6 years presenting to the ED with croup were eligible for inclusion if their Westley croup score was 2 or more. They were randomized to receive a single oral dose of either prednisolone 1 mg/kg, dexamethasone 0.15 mg/kg or dexamethasone 0.6 mg/kg. Primary outcome measures were the magnitude and rate of reduction in Westley croup score, rate of return for medical care with ongoing croup, and further treatment with steroids in the week following index presentation. Secondary outcome measures were the proportion of subjects requiring admission or salvage therapy, such as nebulized adrenaline, during index presentation. Results: A total of 99 children, aged 6-79 months, were enrolled (mean age: 1.7 years). Thirty-four patients were randomized to receive prednisolone 1 mg/kg, 34 to receive dexamethasone 0.15 mg/kg, and 31 to receive dexamethasone 0.6 mg/kg. Baseline characteristics of the three groups were similar. The parents of 86 patients (87%) were available for follow-up telephone interview at 1 week. There were no significant differences in primary or secondary outcome measures between the three treatment groups. Conclusions: Both prednisolone 1 mg/kg and low-dose dexamethasone (0.15 mg/kg) were found not to differ in efficacy from the currently recommended 0.6 mg/kg dexamethasone. The use of these corticosteroid regimens in treating patients with mild to moderate croup is thus supported.