Prednisolone Versus Dexamethasone for Croup: a Randomized Controlled Trial.

Abstract

OBJECTIVES:

The use of either prednisolone or low-dose dexamethasone in the treatment of childhood croup lacks a rigorous evidence base despite widespread use. In this study, we compare dexamethasone at 0.6 mg/kg with both low-dose dexamethasone at 0.15 mg/kg and prednisolone at 1 mg/kg.

METHODS:

Prospective, double-blind, noninferiority randomized controlled trial based in 1 tertiary pediatric emergency department and 1 urban district emergency department in Perth, Western Australia. Inclusions were age >6 months, maximum weight 20 kg, contactable by telephone, and English-speaking caregivers. Exclusion criteria were known prednisolone or dexamethasone allergy, immunosuppressive disease or treatment, steroid therapy or enrollment in the study within the previous 14 days, and a high clinical suspicion of an alternative diagnosis. A total of 1252 participants were enrolled and randomly assigned to receive dexamethasone (0.6 mg/kg; n = 410), low-dose dexamethasone (0.15 mg/kg; n = 410), or prednisolone (1 mg/kg; n = 411). Primary outcome measures included Westley Croup Score 1-hour after treatment and unscheduled medical re-attendance during the 7 days after treatment.

RESULTS:

Mean Westley Croup Score at baseline was 1.4 for dexamethasone, 1.5 for low-dose dexamethasone, and 1.5 for prednisolone. Adjusted difference in scores at 1 hour, compared with dexamethasone, was 0.03 (95% confidence interval -0.09 to 0.15) for low-dose dexamethasone and 0.05 (95% confidence interval -0.07 to 0.17) for prednisolone. Re-attendance rates were 17.8% for dexamethasone, 19.5% for low-dose dexamethasone, and 21.7% for prednisolone (not significant [P = .59 and .19]).

CONCLUSIONS:

Noninferiority was demonstrated for both low-dose dexamethasone and prednisolone. The type of oral steroid seems to have no clinically significant impact on efficacy, both acutely and during the week after treatment.

• Authors: Colin M Parker, Matthew N Cooper
• Journal: Pediatrics (Pediatrics) Vol. 144 Issue 3 (09 2019) ISSN: 1098-4275 [Electronic] United States
• PMID: 31416827 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2019 by the American Academy of Pediatrics.

Chemical References

• Glucocorticoids
• Dexamethasone
• Prednisolone

Topics

• Administration, Oral
• Child, Preschool
• Croup (drug therapy)
• Dexamethasone (administration & dosage, adverse effects, therapeutic use)
• Double-Blind Method
• Drug Administration Schedule
• Emergency Service, Hospital
• Equivalence Trials as Topic
• Female
• Glucocorticoids (administration & dosage, adverse effects, therapeutic use)
• Humans
• Infant
• Male
• Prednisolone (administration & dosage, adverse effects, therapeutic use)
• Prospective Studies
• Western Australia