The efficacy of nebulized budesonide in dexamethasone-treated outpatients with croup.
OBJECTIVE
To determine the added clinical benefit of nebulized budesonide in children with mild to moderate croup treated with 0.6 mg/kg oral dexamethasone.


METHODS
Randomized, double-blind, placebo-controlled trial.


METHODS
Emergency department of a tertiary-care pediatric hospital with 47,000 visits per year.


METHODS
Children 3 months to 5 years of age with a syndrome consisting of hoarseness, inspiratory stridor, and barking cough and a croup score of 3 or greater after at least 15 minutes of mist therapy. Patients were excluded from the study if they had diagnoses of epiglottitis, chronic upper or lower airway disease (not including asthma), or severe croup or had received corticosteroids within the preceding 2 weeks.


METHODS
All patients received 0.6 mg/kg oral dexamethasone and were randomly assigned to receive 4 mL (2 mg) of budesonide solution (n=25) or 4 mL of 0.9% saline solution (n=25) by updraft nebulizer with a continuous flow of oxygen at 5 to 6 L/min.


METHODS
The primary outcome measure was the proportion of patients in each group who had clinically important changes (two points) in the croup score during the 4 hours after treatment.


RESULTS
Eighty-four percent (n=21) of the patients who received budesonide had clinically important responses, compared with 56% (n=14) in the placebo group. The number of patients who would need to be treated with nebulized budesonide for one patient to have a clinically important response is four patients.


CONCLUSIONS
Despite receiving simultaneous oral dexamethasone, pediatric outpatients with mild to moderate croup have added, clinically important improvement in respiratory symptoms after treatment with budesonide.
Klassen
T P
TP
Department of Pediatrics, University of Ottawa, Ontario, Canada.
Watters
L K
LK
Feldman
M E
ME
Sutcliffe
T
T
Rowe
P C
PC
D000284:Administration, Oral; D000287:Administration, Topical; D000553:Ambulatory Care; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D019819:Budesonide; D002675:Child, Preschool; D003243:Consciousness; D003371:Cough / Q000188:drug therapy; D003440:Croup / Q000188:drug therapy*; D003490:Cyanosis / Q000188:drug therapy; D003907:Dexamethasone / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids; D006339:Heart Rate / Q000187:drug effects; D006685:Hoarseness / Q000188:drug therapy; D006801:Humans; D007223:Infant; D008297:Male; D009330:Nebulizers and Vaporizers; D010102:Oxygen Inhalation Therapy; D011282:Pregnenediones / Q000627:therapeutic use*; D012123:Pulmonary Ventilation / Q000187:drug effects; D012119:Respiration / Q000187:drug effects; D012135:Respiratory Sounds / Q000187:drug effects; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D001993:Bronchodilator Agents; D005938:Glucocorticoids; D011282:Pregnenediones; D019819:Budesonide; D003907:Dexamethasone