CompletedPhase 3Phase 4ACTRN12605000447651

Comparison between single dose oral prednisolone and oral dexamethasone in the treatment of croup: a randomised, double-blind clinical trial.

A randomised, double-blind clinical trial comparing the effectiveness of single dose oral prednisolone versus single dose oral dexamethasone in reducing the severity of croup in children presenting to the Emergency Department, as measured by changes in the Westley croup score.


Sponsor

Mater Childrens' Hospital Department of Paediatric Emergency Medicine

Enrollment

100 participants

Start Date

Jul 7, 2004

Study Type

Interventional

Conditions

Summary

Published: Emergency Medicine Australasia (2007) 19, 51–58 ABSTRACT 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.


Eligibility

Sex: Both males and femalesMin Age: 6 MonthssMax Age: 6 Yearss

Plain Language Summary

Simplified for easier understanding

This trial compares two steroid medications, prednisolone and dexamethasone, for treating croup in young children. Children aged 6 months to 6 years with croup symptoms like barking cough and noisy breathing are eligible. Participation involves receiving a single dose of one of the two medicines and being monitored for improvement.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Three steroid preparations are being compared in a double-blinded, randomised trial. Children aged 6 months to 6 years presenting to Brisbane's Mater Childrens' Hospital Emergency Department (MC

Three steroid preparations are being compared in a double-blinded, randomised trial. Children aged 6 months to 6 years presenting to Brisbane's Mater Childrens' Hospital Emergency Department (MCH ED) with moderate severity croup (defined in the study as Westley croup score 2-7) are randomised to one of three treatment groups: oral dexamethasone 0.6mg/kg, oral dexamethasone 0.15mg/kg, or prednisolone 1mg/kg. After administration of their oral dose of steroid treatment, the children are observed in the ED for up to 4 hours, with hourly measurement of their Westley croup score. Subjects are able to be discharged from ED earlier than 4 hours if much improved; if they are still significantly symptomatic at 4hrs they may be admitted to the ward for observation. Salvage therapy such as nebulised adrenaline can be provided at the discretion of the treating doctor. The subject's discharge or admission is at the discretion of the ED clinician looking after the patient. If the child re-presented to a health care facility following the index presentation, additional treatment was at the discretion of the treating doctor. A phone call was made to the parents of enrolled children 1-2weeks after their index presentation to discuss the duration of the child's croup symptoms, need for medical review with or without further steroids, and to discuss any noted side effects from the steroid preparation.


Locations(1)

QLD, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12605000447651