Prednisolone versus dexamethasone in croup: a randomised equivalence trial

Background

Croup remains a common respiratory problem presenting to emergency departments. A single oral treatment of oral dexamethasone results in improved outcome. Prednisolone has similar pharmacokinetic properties and has a significant advantage in that it is commercially available in liquid preparations.

Objective

To ascertain whether a single oral dose of prednisolone was equivalent to a single oral dose of dexamethasone (matched for potency) in children with mild to moderate croup.

Design

A double blind, randomised, controlled equivalence trial

Setting

Tertiary paediatric emergency department.

Patients

133 children aged 3 to 142 months presenting with mild to moderate croup.

Interventions

Children received either a single oral dose of dexamethasone 0.15 mg/kg or single oral dose of prednisolone 1 mg/kg.

Outcome

The main outcome measure was unscheduled re‐presentation to medical care as determined by telephone follow up at 7 to 10 days. Croup score, adrenaline (epinephrine) use, time spent in the emergency department, and duration of croup and viral symptoms were secondary outcome measures.

Results

Children treated with prednisolone were more likely to re‐present: 19 of 65 children (29%) reattended medical care compared with 5 of 68 (7%) from the dexamethasone group. The confidence intervals around this 22% difference in outcome were 8% to 35%, outside the 0% to 7.5% range of equivalence. There were no significant differences in other outcome measures.

Conclusion

A single oral dose of prednisolone is less effective than a single oral dose of dexamethasone in reducing unscheduled re‐presentation to medical care in children with mild to moderate croup.