Nebulized budesonide and oral dexamethasone for treatment of croup: a randomized controlled trial. Budesonide offers no advantage when added to oral dexamethasone in the treatment of croup. The efficacy of nebulized budesonide in dexamethasone-treated outpatients with croup. [Inhaled budesonide versus intramuscular dexamethasone in the treatment of pseudo-croup]. Oral and inhaled steroids in croup: a randomized, placebo-controlled trial. Double blind placebo controlled trial of nebulised budesonide for croup. Oral betamethasone versus intramuscular dexamethasone for the treatment of mild to moderate viral croup: a prospective, randomized trial. Outpatient treatment of croup with nebulized dexamethasone. A comparison of nebulized budesonide, intramuscular dexamethasone, and placebo for moderately severe croup.
The effectiveness of glucocorticoids for patients with croup is well established but it remains uncertain which glucocorticoid regimen is most effective.
                To determine the effectiveness of 3 glucocorticoid regimens in patients with croup.
                Randomized controlled trial with parallel design.
                Emergency departments of 2 Canadian pediatric tertiary care hospitals.
                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.
                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.
                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.
                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).
                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. To evaluate the effect of adding inhaled budesonide (2 mg) to oral dexamethasone 0.15 mg/kg in children hospitalized with croup.
                Observation ward of a Tertiary Paediatric Hospital Emergency Department.
                Seventy-two children (age range 3 to 126 months) hospitalized with croup.
                Children randomized to receive either 2 mg of nebulized budesonide or placebo, with all children receiving a single oral dose of 0.15 mg/kg dexamethasone.
                Primary outcome was duration of hospital stay. Other measures included croup scores from 0 to 12 hours, use of nebulized epinephrine, duration of croup symptoms, duration of viral symptoms, and return to medical care for croup or for any other reason following discharge from hospital.
                Baseline characteristics for the 2 groups were similar. There was no difference in time to discharge for the 2 groups or for other outcome measures with a risk ratio of 1.3 (95% confidence intervals of 0.82 and 2.1).
                The addition of inhaled budesonide (2 mg) to oral dexamethasone (0.15 mg/kg) offers no advantage in the treatment of children hospitalized with croup. To determine the added clinical benefit of nebulized budesonide in children with mild to moderate croup treated with 0.6 mg/kg oral dexamethasone.
                Randomized, double-blind, placebo-controlled trial.
                Emergency department of a tertiary-care pediatric hospital with 47,000 visits per year.
                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.
                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.
                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.
                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.
                Despite receiving simultaneous oral dexamethasone, pediatric outpatients with mild to moderate croup have added, clinically important improvement in respiratory symptoms after treatment with budesonide. We randomised 59 children hospitalized for croup to treatment with either inhaled budesonide or injected dexamethasone. Group A were treated with two inhalations of 1000 micrograms budesonide and group B received dexamethasone 0.6 mg/kg intramuscularly. We used a modified Westley-score, based on chest-wall retractions, barking cough, respiratory frequency and stridor. The children was aged three months to six years (mean 20 months). Three hours after the first treatment there was significant improvement in score amongst all children (p < 0.001), but no difference between the two groups (p < 0.20). Six and 12 hours after the first treatment there were significantly better clinical scores in group B (p = 0.001, p = 0.0004). Based on this study we recommend dexamethasone 0.6 mg/kg intramuscularly for children to be treated for croup. It was the objective of this study to compare the efficacy of oral dexamethasone and inhaled budesonide in children hospitalized with croup, using a three-way, double blind, randomized, placebo-controlled clinical trial design. The trial was carried out in the Emergency Department Observation Ward of a tertiary pediatric hospital. The subjects for the study were 80 children (age range 5 to 158 months) who were hospitalized with croup. Children received either 2 mg of nebulised budesonide, dexamethasone syrup (0.6 mg/kg) or a placebo. Median duration of hospitalization was shorter for children treated with dexamethasone (12 hr) and budesonide (13 hr) compared to placebo (20 hr) (P < 0.03). There was no significant difference in hospitalization time between children treated with dexamethasone and budesonide. Median time to a croup score of < or = 1 was shorter for children treated with dexamethasone (2 hr) or budesonide (3 hr) compared to those who received placebo (8 hr) (P < 0.01). Croup scores for both steroid groups were significantly lower than the placebo group by 1 hr and remained so subsequently. The croup scores did not differ significantly in the 2 steroid treated groups. Six of the 30 children (20%) in the placebo group required adrenaline after the first hour compared to none of the 50 children in the steroid treated groups (P < 0.02). We conclude that oral dexamethasone and inhaled budesonide are both effective in reducing symptoms and duration of hospitalization in children with croup. To determine whether nebulised budesonide improves the symptoms or shortens the duration of stay of children admitted to hospital with a clinical diagnosis of croup.
                A prospective, randomised, double blind placebo controlled trial. Patients received either nebulised budesonide or placebo every 12 hours. The main outcome measures were duration of inpatient stay and croup scores at 30 minutes, one, two, four, 12, and 24 hours.
                87 patients (89 admissions) aged 7-116 months entered the trial. Nebulised budesonide was associated with a significant improvement in symptoms at 12 hours (95% confidence interval (CI) 1 to 3) and 24 hours (95% CI 0 to 3). Patients with an initial croup score above 3 demonstrated a significant improvement in symptoms at two hours (95% CI 1 to 3). Nebulised budesonide was also associated with a 33% reduction in the length of stay (95% CI 2% to 63%) when the confounding variables of age, initial croup score, and coryzal symptoms were taken into consideration.
                Nebulised budesonide is an effective treatment for children admitted to hospital with a clinical diagnosis of croup. Intramuscular dexamethasone is an effective, but painful, treatment for croup. The effectiveness of betamethasone, an oral, palatable, and equally potent glucocorticoid has not been studied. The purpose of this study was to compare the effectiveness of a single oral dose of betamethasone with intramuscular dexamethasone in the outpatient treatment of mild to moderate croup.
                Children aged 6 months to 6 years presenting to a tertiary care pediatric emergency department (ED) with a modified Westley croup score of 0 to 11 were randomized to receive either 0.6 mg/kg IM dexamethasone or 0.4 mg/kg PO betamethasone. Croup score, heart rate, respiratory rate, pulse oximetry, and need for supplemental treatments were recorded at study entry and at 1, 2, and 4 hours after treatment. Follow-up data were collected by daily telephone follow-up on persistence of symptoms and the need for additional treatment or physician visits up to 7 days after the ED visit.
                Each study group contained 26 patients. Despite randomization, the mean baseline croup score was higher in the dexamethasone group (3.6 +/- 2.6 vs. 2.0 +/- 2.4, P = 0.03). Patients in both groups showed a significant reduction in the croup score after treatment, and there were no significant differences between croup scores at 4 hours (P = 0.18). Similarly, there were no differences between groups in the hospital admission rate, time to resolution of symptoms, need for additional treatments, or number of return ED visits.
                There is no difference between oral betamethasone and intramuscular dexamethasonein the management of mild to moderate viral croup. It is palatable and does not require a nurse for administration, making it a good alternative for ambulatory management. 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.
                Randomized, double-blind, placebo controlled trial.
                Emergency department, children's hospital.
                Fifty-five children with croup who were in moderate respiratory distress after treatment with mist for 30 minutes who met inclusion and exclusion criteria.
                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.
                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.
                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. 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.
                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.
                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).
                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.
Dexamethasone and budesonide are effective in relieving the symptoms of croup as early as six hours after treatment. Fewer return visits and/or (re)admissions are required and the length of time spent in hospital is decreased. Research is required to examine the most beneficial method for disseminating croup practice guidelines and to increase the uptake of evidence.