D W Johnson1, S Schuh, G Koren, D M Jaffee. 1. Division of Emergency Medicine, Department of Paediatrics, Hospital for Sick Children, University of Toronto, Ontario, Canada.
Abstract
PURPOSE: To determine if treating children who have acute, moderate croup withnebulized dexamethasone sodium phosphate in the emergency department results in clinical improvement by 4 hours and a decrease in the hospitalization rate. DESIGN: Randomized, double-blind, placebo controlled trial. SETTING:Emergency department, children's hospital. PATIENTS: Fifty-five children with croup who were in moderate respiratory distress after treatment with mist for 30 minutes who met inclusion and exclusion criteria. MEASUREMENTS: Croup score, respiratory rate, heart rate, and oxygen saturation were assessed by one of us (D.W.J. or S.S.) before treatment and 2 and 4 hours after treatment. A staff pediatrician or senior pediatric resident, also "blind" to treatment, decided on admission to or discharge from the hospital. The differences between groups for change in croup score and hospitalization rate after treatment were analyzed. RESULTS: Evaluation of the croup scores disclosed a significant improvement in the dexamethasone-treated group compared with the placebo group at 4 hours (P=.005, Mann-Whitney U). However, the hospitalization rate was not statistically different at the end of treatment (33% vs 52%, P=.28) or after 24 hours (48% vs 60%, P=.56, Yates corrected chi(2)). Our study has 80% power to detect a two-thirds reduction in hospitalization rate. Two patients with neutropenia treated withdexamethasone had a clinical course consistent with bacterial tracheitis. CONCLUSIONS: Treatment of moderate croup with nebulized dexamethasone results in clinical improvement within 4 hours. We did not show a decrease in hospitalization rates, although our sample size was only large enough to detect a 67% reduction in the rate of hospitalization. Given the infectious complications and the absence of evidence for a sustained clinical effect, we do not recommend that patients with croup be treated withnebulized dexamethasone.
RCT Entities:
PURPOSE: To determine if treating children who have acute, moderate croup with nebulized dexamethasone sodium phosphate in the emergency department results in clinical improvement by 4 hours and a decrease in the hospitalization rate. DESIGN: Randomized, double-blind, placebo controlled trial. SETTING: Emergency department, children's hospital. PATIENTS: Fifty-five children with croup who were in moderate respiratory distress after treatment with mist for 30 minutes who met inclusion and exclusion criteria. MEASUREMENTS: Croup score, respiratory rate, heart rate, and oxygen saturation were assessed by one of us (D.W.J. or S.S.) before treatment and 2 and 4 hours after treatment. A staff pediatrician or senior pediatric resident, also "blind" to treatment, decided on admission to or discharge from the hospital. The differences between groups for change in croup score and hospitalization rate after treatment were analyzed. RESULTS: Evaluation of the croup scores disclosed a significant improvement in the dexamethasone-treated group compared with the placebo group at 4 hours (P=.005, Mann-Whitney U). However, the hospitalization rate was not statistically different at the end of treatment (33% vs 52%, P=.28) or after 24 hours (48% vs 60%, P=.56, Yates corrected chi(2)). Our study has 80% power to detect a two-thirds reduction in hospitalization rate. Two patients with neutropenia treated with dexamethasone had a clinical course consistent with bacterial tracheitis. CONCLUSIONS: Treatment of moderate croup with nebulized dexamethasone results in clinical improvement within 4 hours. We did not show a decrease in hospitalization rates, although our sample size was only large enough to detect a 67% reduction in the rate of hospitalization. Given the infectious complications and the absence of evidence for a sustained clinical effect, we do not recommend that patients with croup be treated with nebulized dexamethasone.
Authors: Allison Gates; Michelle Gates; Ben Vandermeer; Cydney Johnson; Lisa Hartling; David W Johnson; Terry P Klassen Journal: Cochrane Database Syst Rev Date: 2018-08-22