PEDIATRICS Vol. 97 No. 5 May 1996, pp. 722-725
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Nebulized Budesonide Is as Effective as Nebulized Adrenaline in Moderately Severe Croup

Dominic Fitzgerald MBBS, FRACP1, Craig Mellis MBBS, MPH, FRACP2, Mark Johnson MBBS3, Hugh Allen MBBS, FRACP4, Peter Cooper MB, ChB, MRCP, FRACP5, and Peter Van Asperen MD, FRACP6

1 Department of Respiratory Medicine, Royal Alexandra Hospital for Children
2 Clinical Epidemiology and Biostatistics, Royal Alexandra Hospital for Children; Department of Respiratory Medicine Royal Alexandra Hospital for Children, Australia
3 Department of Pediatrics, Westmead Hospital, Australia
4 Department of Paediatrics, Royal North Shore Hospital, Sydney, Australia
5 Department of Pediatrics, Westmead Hospital Sydney, Australia
6 Department of Respiratory Medicine Royal Alexandra Hospital for Children

Objective. Nebulized budesonide and nebulized adrenaline have been shown to be effective in the treatment of moderately severe croup. However, there has been no direct comparison of these therapies. We undertook a multicenter, randomized, double-blind, parallel group study in 66 hospitalized children with viral or spasmodic croup.

Methods. Children 0.5 to 6 years of age were assessed using a validated croup symptom score (stridor, 0 through 4; cough, 0 through 3; retractions, 0 through 3; dyspnea, 0 through 3; and color, 0 through 4) at 0.5, 1, 1.5, 2, 12, and 24 hours after nebulization. Patients received either budesonide (2 mg/4 mL) or L-adrenaline (4 mg/4 mL) via nebulization. The primary outcome measure was change in the total croup symptom score.

Results. Thirty-five children received budesonide and 31 received adrenaline. There was no significant difference in baseline features, including croup score (mean [95% confidence interval]: budesonide, 7.1 [6.7- 7.5]; adrenaline, 7.7 [7.3-8.1]). All patients had significant improvement from baseline, and there was no significant difference between the two treatments, as measured by change in croup scores, change in oxygen saturation, duration of hospitalization, number of subsequent treatments with systemic steroids or adrenaline, and adverse events. No child required intubation.

Conclusion. This study does not show any difference in efficacy and safety between nebulized budesonide and nebulized adrenaline in the treatment of acute upper airway obstruction in patients with moderately severe croup.

Submitted on May 10, 1995
Accepted on September 12, 1995




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