June 1996
TORONTO — Investigators who used nebulized dexamethasone as outpatient treatment for children with moderately severe croup found that the treatment did not reduce the children's likelihood of being hospitalized, according to a recent report.
The treatment did produce significant improvement in clinical condition when compared with children who did not receive nebulized dexamethasone, although the investigators found no evidence that the treatment produced a sustained clinical effect, according to the report.
Study data suggested that "at this point, the use of nebulized dexamethasone is not warranted," said lead investigator David W. Johnson, MD, assistant professor of pediatrics at the University of Calgary in Alberta.
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Investigators randomly assigned 55 children with moderately severe croup to receive either dexamethasone or saline (the control group). A staff pediatrician or senior pediatric resident evaluated patients two and four hours after treatment. The study protocol allowed evaluating physicians, who were blinded to treatment, to discharge patients from the hospital at two hours. At four hours, the supervising physician made a final decision whether to admit patients to the hospital or discharge them.
At four hours, the dexamethasone group showed significant clinical improvement when compared with the control group. The groups showed no statistically significant difference in hospitalization rates, however. The sample size was only large enough to detect a 67% decrease in the hospitalization rate, according to the investigators.
The findings were published in the April issue of Archives of Pediatric & Adolescent Medicine.
The investigators excluded three patients from the analysis of hospitalization data because a staff physician decided to hospitalize the children before evaluating them four hours after treatment, Johnson said. One patient was in the treatment group and two were in the placebo group.
Four hours after treatment, nine of 27 (33%) children in the dexamethasone group were hospitalized, compared with 13 of 25 patients (52%) in the control group. Twenty-four hours after treatment, 13 of 27 (48%) children in the dexamethasone group were hospitalized, compared with 15 of 25 children (60%) in the control group. None of the differences between the treatment and control groups were statistically significant.
Bacterial tracheitis developed in two patients with neutropenia who received nebulized dexamethasone. These patients required prolonged intubation, the investigators reported. "Our observation of infectious complications in two immunosuppressed patients, although possibly coincidental, concern us," the investigators stated. "Given these concerns and the absence of evidence of a sustained clinical effect, we do not recommend that patients with croup be treated with nebulized dexamethasone."
According to published findings from prospective clinical trials, bacterial tracheitis as a complication of treating croup with systemic corticosteroids has not been reported, Johnson and colleagues stated. Bacterial tracheitis develops in about 1% to 2% of children hospitalized for croup. Therefore, "it is unlikely that systemic corticosteroids notably increase the risk for developing bacterial tracheitis among previously healthy children," they said.
Johnson and colleagues are working on a three-arm trial comparing inhaled budesonide with intramuscular dexamethasone with placebo in a similar study population. The investigators hope to enroll 210 children.
In an editorial accompanying the report by the Johnson team, Peter C. Rowe, MD, of Johns Hopkins University, Baltimore, and Terry P. Klassen, MD, of the University of Manitoba, Winnipeg, summed up what research data say about corticosteroid therapy for children with croup. For hospitalized patients with croup, they stated, strong evidence supports routine use of oral or parenteral glucocorticoids or nebulized budesonide. In addition, for outpatients with croup of mild to moderate severity (croup scores of 2 or greater), strong evidence supports the routine use of single doses of nebulized budesonide or parenteral glucocorticoids.
For more information, see:
- Johnson DW, Schuh S, Koren G, Jaffe DM. Outpatient treatment of croup with nebulized dexamethasone. Arch Pediatr Adolesc Med. 1996;150:349-55.
- Rowe PC, Klassen TP. Corticosteroids for croup. Arch Pediatr Adolesc Med. 1996;150:344-46.
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