A comparison of nebulized budesonide, intramuscular dexamethasone, and placebo for moderately severe croup

N Engl J Med. 1998 Aug 20;339(8):498-503. doi: 10.1056/NEJM199808203390802.


Background: In children with croup, treatment with nebulized budesonide decreases symptoms, but it is uncertain how budesonide compares with dexamethasone, the conventional therapy for croup, and whether either reduces the rate of hospitalization.

Methods: We performed a double-blind, randomized trial involving 144 children with moderately severe croup. The children were treated with racepinephrine and a single dose of 4 mg of nebulized budesonide (48 children), 0.6 mg of intramuscular dexamethasone per kilogram of body weight (47 children), or placebo (49 children). The children were assessed before treatment and then hourly for five hours after treatment. Physicians who were unaware of the treatment assignments determined the children's need for further treatment and hospitalization.

Results: The characteristics of the groups were similar at base line, including the types of viruses identified, the types of croup, and the clinical severity of the illness. The overall rates of hospitalization were 71 percent in the placebo group (35 of 49 children), 38 percent in the budesonide group (18 of 48 children), and 23 percent in the dexamethasone group (11 of 47 children) (unadjusted P=0.001 for the comparison of budesonide with placebo, P<0.001 for the comparison of dexamethasone with placebo, and P=0.18 for the comparison of budesonide with dexamethasone). Children treated with budesonide or dexamethasone had a greater improvement in croup scores than those given placebo (P=0.03 and P<0.001, respectively), and those treated with dexamethasone had a greater improvement than those treated with budesonide (P=0.003).

Conclusions: In children with moderately severe croup, treatment with intramuscular dexamethasone or nebulized budesonide resulted in more rapid clinical improvement than did the administration of placebo, with dexamethasone offering the greatest improvement. Treatment with either glucocorticoid resulted in fewer hospitalizations.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Analysis of Variance
  • Bronchodilator Agents / therapeutic use
  • Budesonide / administration & dosage
  • Budesonide / therapeutic use*
  • Child, Preschool
  • Croup / drug therapy*
  • Croup / virology
  • Dexamethasone / administration & dosage
  • Dexamethasone / therapeutic use*
  • Double-Blind Method
  • Emergency Service, Hospital
  • Epinephrine / therapeutic use
  • Female
  • Glucocorticoids / administration & dosage
  • Glucocorticoids / therapeutic use*
  • Hospitalization / statistics & numerical data
  • Humans
  • Infant
  • Injections, Intramuscular
  • Logistic Models
  • Male
  • Nasopharynx / virology
  • Nebulizers and Vaporizers
  • Racepinephrine


  • Bronchodilator Agents
  • Glucocorticoids
  • Budesonide
  • Dexamethasone
  • Racepinephrine
  • Epinephrine