Nebulized budesonide and oral dexamethasone for treatment of croup: a randomized controlled trial.

CONTEXT: The effectiveness of glucocorticoids for patients with croup is well established but it remains uncertain which glucocorticoid regimen is most effective. OBJECTIVE: To determine the effectiveness of 3 glucocorticoid regimens in patients with croup. DESIGN: Randomized controlled trial with parallel design. SETTING: Emergency departments of 2 Canadian pediatric tertiary care hospitals. PARTICIPANTS: Children with a clinical syndrome consistent with croup, aged 3 months to 5 years, with a croup score of 2 or greater following at least 15 minutes of mist therapy. INTERVENTIONS: Oral dexamethasone, 0.6 mg/kg, and nebulized placebo; oral placebo and nebulized budesonide, 2 mg; or oral dexamethasone, 0.6 mg/kg, and nebulized budesonide, 2 mg. MAIN OUTCOME MEASURES: Westley croup score (primary outcome), hospital admission rates, time spent in the emergency department, return visits to the emergency department, or ongoing symptoms at 1 week. RESULTS: The mean change in the croup score from baseline to the final study assessment was -2.3 (95% confidence interval [CI], -2.6 to -2.0) in the budesonide group (n = 65), -2.4 (95% CI, -2.6 to -2.2) in the dexamethasone group (n = 69), and -2.4 (95% CI, -2.7 to -2.1) in the budesonide and dexamethasone group (n = 64, P = .70). CONCLUSIONS: Based on the similar outcomes in the 3 groups, oral dexamethasone is the preferred intervention because of its ease of administration, lower cost, and more widespread availability.

Dexamethasone in salbutamol-treated inpatients with acute bronchiolitis: a randomized, controlled trial.

OBJECTIVE: To determine the clinical benefit of oral dexamethasone in children admitted to the hospital with bronchiolitis treated with nebulized salbutamol. METHODS: Randomized, double-blind, placebo-controlled trial in the inpatient wards of a pediatric tertiary care hospital. The participants, children aged 6 weeks to 15 months, admitted with first-time wheezing, were eligible if their oxygen saturation was less than 95% on admission to the hospital and their Respiratory Distress Assessment Instrument (RDAI) score was greater than 6. Patients were excluded if they had any one of the following: an underlying disease that might affect cardiopulmonary status, asthma, recent treatment with steroids (within 2 weeks), or any history of adverse reaction to steroids. Patients were randomly assigned to receive either orally administered dexamethasone with 0.5 mg/kg as the first dose and 0.3 mg/kg for the next 2 mornings, or an equal volume of an orally administered placebo with an identical appearance. All patients received nebulized salbutamol at 0.15 mg/kg every 4 hours for the first 24 hours. The primary outcome measure was the change from baseline in the RDAI score at 24 hours. Secondary outcome measures were oxygen saturation, respiratory rate, RDAI measurement twice daily for the first 4 days, and the length of hospitalization. RESULTS: At 24 hours the mean change (SD) from baseline in the RDAI score was 1.6 (2.3) in the placebo group (n = 28) and 1.4 (2.0) in the dexamethasone group (n = 33; p = 0.74). There were no significant differences between the two groups in change in oxygen saturation, respiratory rate, and RDAI score at any assessment period. The median length of stay (95% confidence interval) for the placebo group was 48 (42, 54) hours compared with 57 (38, 76) hours in the dexamethasone group (p = 0.19). CONCLUSIONS: Oral dexamethasone therapy does not affect the clinical course of children hospitalized with bronchiolitis and therefore cannot be recommended in this clinical situation.

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. DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Emergency department of a tertiary-care pediatric hospital with 47,000 visits per year. PARTICIPANTS: 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. INTERVENTION: 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. MAIN OUTCOME MEASURES: 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.

Nebulized budesonide for children with mild-to-moderate croup.

BACKGROUND: Although recent evidence has strongly supported the use of glucocorticoid therapy in children hospitalized with croup, the benefit of this therapy in children with less severe croup has not been documented. This randomized, double-blind trial compared a nebulized glucocorticoid, budesonide, with placebo in outpatients with mild-to-moderate croup. METHODS: Children three months to five years of age were eligible for the study if their croup scores fell in the mild-to-moderate range (scores of 2 to 7 out of a possible 17). The patients were randomly assigned to receive either 2 mg (4 ml) of nebulized budesonide (27 children) or 4 ml of nebulized normal saline (27 children); they were then assessed hourly for up to four hours by investigators who were unaware of the assigned treatments. RESULTS: The median croup score at entry into the study was 4 in both groups. At the final study assessment, the median score was significantly lower in the budesonide group than in the placebo group (1 vs. 3, P = 0.005). The patients in the budesonide group were discharged from the emergency department significantly earlier than those in the placebo group (P = 0.002). One week after enrollment, 21 patients assigned to placebo had received dexamethasone, as compared with 15 patients assigned to budesonide (P = 0.10), and 7 patients assigned to placebo had been admitted to the hospital, as compared with 1 patient assigned to budesonide (P = 0.05). CONCLUSIONS: We conclude that nebulized budesonide leads to a prompt and important clinical improvement in children with mild-to-moderate croup who come to the emergency department.