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. Repeated dose inhaled budesonide versus placebo in the treatment of croup. A comparison of nebulized budesonide, and intramuscular, and oral dexamethasone for treatment of croup. Treatment of croup with nebulised steroid (budesonide): a double blind, placebo controlled study. Efficacy of a small single dose of oral dexamethasone for outpatient croup: a double blind placebo controlled clinical trial. Outpatient treatment of moderate croup with dexamethasone: intramuscular versus oral dosing. A prospective randomized study to determine the efficacy of steroids in treatment of croup. Use of dexamethasone in the outpatient management of acute laryngotracheitis. A randomized trial of a single dose of oral dexamethasone for mild croup. Oral dexamethasone in the treatment of croup: 0.15 mg/kg versus 0.3 mg/kg versus 0.6 mg/kg. Nebulized budesonide for children with mild-to-moderate croup. A prospective randomized double-blind study to evaluate the effect of dexamethasone in acute laryngotracheitis. Comparison between single-dose oral prednisolone and oral dexamethasone in the treatment of croup: a randomized, double-blinded clinical trial. A randomized double-blind, placebo-controlled trial of dexamethasone and racemic epinephrine in the treatment of croup. Nebulized budesonide is as effective as nebulized adrenaline in moderately severe croup. Steroid treatment of pseudo-croup. Budesonide prolongs time to relapse in ileal and ileocaecal Crohn's disease. A placebo controlled one year study. Effectiveness of oral or nebulized dexamethasone for children with mild croup. Prednisolone versus dexamethasone in croup: a randomised equivalence trial. Effectiveness of oral dexamethasone in the treatment of moderate to severe pharyngitis in children. Use of dexamethasone to reduce postoperative vomiting and pain after pediatric tonsillectomy procedures. Dexamethasone for the prevention of postextubation airway obstruction: a prospective, randomized, double-blind, placebo-controlled trial. Nebulised L-epinephrine and steroid combination in the treatment of moderate to severe croup. Corticosteroid treatment of laryngotracheitis v spasmodic croup in children. A multicenter, randomized open study of early corticosteroid treatment (OSECT) in preterm infants with respiratory illness: comparison of early and late treatment and of dexamethasone and inhaled budesonide. [Randomized double-blind study of treatment of croup with adrenaline and/or dexamethasone in children].
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. To investigate the efficacy and tolerance of 12-hourly dosing with 2 mg 4 mL-1 of inhaled budesonide versus placebo in patients admitted to hospital with moderate/severe croup.
                Eighty-two children hospitalised with croup received either 2 mg 4 mL-1 of budesonide or placebo 12 hourly (maximum four doses) via Ventstream nebuliser in a randomised, double-blind manner. Croup scores were performed at 0, 2, 6, 12, 24, 36 and 48 h from initial nebulisation whilst the patient remained hospitalised. Follow-up assessments were made 1 and 3 days after discharge.
                Improvement was observed in the budesonide group over the 12-h dosing interval when compared to placebo (P = 0.04). Time to attain a significant clinical improvement was superior in the budesonide group (P = 0.01). Three days after discharge seven of 32 placebo-treated patients and one of 34 budesonide-treated patients had sought further medical follow-up (P = 0.02).
                Twelve-hourly dosing with inhaled budesonide significantly improved symptoms of croup as well as decreased relapse rates when compared with placebo. Croup or acute laryngotracheobronchitis is the most common cause of the upper airway obstruction. Cool mist, nebulized racemic epinephrine and steroids are commonly used for therapy. Although steroid treatment can be applied orally, in nebulized form, or parenterally, no study has compared these three regimens yet. In this study, the efficacy of nebulized budesonide, and oral and intramuscular dexamethasone are compared for treatment of croup.
                Sixty children aged 6-36 months were randomly allocated into four groups. The first three study groups (15 children in each) took nebulized budesonide, oral dexamethasone and intramuscular dexamethasone, respectively, in addition to salbutamol and other supportive measures and these were compared with the placebo group. All patients were evaluated with "Westley Croup Score" on admission to pediatric emergency department (0h) and at 24, 48 and 72h.
                At the end of the study, the croup scores of all steroid treatment groups were significantly lower than the placebo group, but there was no statistical difference among them.
                Nebulized budesonide, oral and parenteral dexamethasone have the same effectiveness for treatment of croup and the choice depends on conditions of the patient and the physician. The aim of this prospective, randomised, double blind study was to evaluate whether nebulised local steroid treatment is effective in the treatment of croup. Thirty six infants and children (0.4-4.9 years of age) admitted to hospital with moderate to severe croup were allocated to receive either 2 mg nebulised budesonide (20 children) or saline (16 children). Disease severity was assessed by a clinical total croup score based on stridor, cough, retractions, dyspnoea, and cyanosis. In addition the overall clinical impression was evaluated (0-100). Two hours after treatment there was a significant improvement in the total croup score in the group treated with budesonide (8 to 4.5), but not in the group treated with saline (8 to 8). Furthermore, the overall clinical impression assessment score decreased significantly (50 to 25) in the group treated with budesonide, whereas it remained constant in the placebo group (60 to 62). The total croup score and overall clinical severity were significantly better in the group treated with budesonide than in the placebo group. No side effects were observed. The results indicate that nebulised budesonide can be used as a safe and effective alternative treatment in children and infants with moderate to severe croup. To assess the efficacy of a single dose of oral dexamethasone 0.15 mg/kg in children with mild croup not admitted to hospital.
                Double blind, randomised, placebo controlled clinical trial.
                The emergency department of a tertiary paediatric hospital.
                100 children aged 4-122 months presenting with mild croup.
                A single oral dose of dexamethasone 0.15 mg/kg or placebo.
                Return to medical care with ongoing croup.
                Baseline characteristics of the two treatment groups were similar. Eight children (all from the placebo group) returned to medical care with ongoing croup, one being admitted. There was no reported difference in duration of croup symptoms, duration of viral symptoms, or rate of return to medical care for other reasons.
                Oral dexamethasone in a dose of 0.15 mg/kg is effective in reducing return to medical care with ongoing croup in children with mild croup. Steroid use for the treatment of croup has been supported by several studies, although few have addressed the use of oral dexamethasone for outpatient management. The efficacy of oral (PO) versus intramuscular (IM) dosing of dexamethasone in the outpatient treatment of moderate croup are compared in this study.
                Patients between the ages of 3 months and 12 years with moderate croup (history or presence of stridor, cyanosis, or retractions) were eligible for enrollment in this single-blind, prospective study. Patients were randomized to receive a single dose (0.6 mg/kg, maximum 8 mg) of IM or PO dexamethasone. Parents were contacted by phone to assess resolution of symptoms and need for further evaluation.
                Two hundred seventy-seven patients were enrolled (median age: 2.1 years). One hundred thirty-nine patients received IM dexamethasone, and 138 received PO. At phone follow-up, 141 (51%) had total resolution of symptoms (75 in IM, 66 in PO). Eighty patients (29%) returned for further evaluation (45 in IM, 35 in PO). Twenty-three (8%) received either more steroids, racemic epinephrine, or admission (11 in IM, 12 in PO).
                No statistically significant difference was found in the need for subsequent interventions after a single dose of either IM or PO dexamethasone. A single PO dose of dexamethasone can be effectively and safely used for the outpatient treatment of moderate croup. We evaluated the use of dexamethasone in the management of acute laryngotracheobronchitis (croup). Thirty patients, ranging in age from eight to 60 months, were evaluated in a prospective, double-blind study. Patients received dexamethasone, 0.3 mg/kg at the time of admission and a similar dose 2 hours later, and were compared with a placebo group receiving saline. Sixteen patients received dexamethasone and 14 patients received the placebo. Severity of each group was scored by a standardized system. Patients receiving dexamethasone had a mean admission score of 8.46 points; patients receiving placebo, 8.14. Twenty-four hours after admission the patients in the treatment group had a mean score of 1.19 as contrasted with a score of 5.58 for the placebo group (P less than 0.01). We concluded that dexamethasone when administered in adequate dosage by an intramuscular route hastens the recovery of infants and children with acute uncomplicated croup. Recent studies have demonstrated that a single intramuscular injection of dexamethasone (0.6 mg/kg) shortens the duration and severity of illness in hospitalized patients with acute viral laryngotracheitis (croup). Our objective was to determine if dexamethasone has a role in the outpatient management of patients with acute viral croup of moderate severity.
                Patients, 6 months to 5 years of age, who came to the emergency department (ED) with acute viral croup, a croup score of at least 2 (range 0 to 17), and a disposition of discharge were randomized in a double-blind fashion to receive a single intramuscular injection of dexamethasone, 0.6 mg/kg, or an equal volume of normal saline before discharge from the ED. Patients were excluded if they had any structural abnormalities, had received any steroids in the preceding 24 hours, or if they required beta-agonist therapy, more than one racemic epinephrine treatment, or hospitalization. Patients were followed up by telephone 24 hours and 7 to 10 days after discharge to determine whether additional medical attention was sought for perceived lack of improvement or worsening of symptoms. Secondary outcome included the parents' perception of how the child was doing at 24 hours, based on a 4-point ordinal scale: worse (1), same (2), improved (3), symptoms resolved (4), and the number of days it took for complete recovery.
                Of the 38 patients comprising the study group, 19 received dexamethasone. The median age was 19 months (range 6 to 66 months), and median pretreatment croup score was 3 (range 2 to 5) for both groups. The number of patients requiring racemic epinephrine was similar in both groups. Five patients sought additional medical attention within 48 hours. Four of the five patients had received placebo (21% of the placebo group) and one had received dexamethasone (5% of the steroid group) (not statistically significant). At the 24-hour telephone follow-up, significantly more patients in the dexamethasone group had a score consistent with improvement compared with placebo (84% vs 42%, P = .003). There was no difference in the number of days for symptoms to completely resolve between the two groups.
                The use of dexamethasone in the outpatient management of viral croup was associated with a reduction in severity of illness within 24 hours after treatment. Patients with viral croup of moderate severity should be considered as candidates for the use of dexamethasone before discharge from the ED. The benefits of dexamethasone treatment for moderate-to-severe croup are well established. However, most children with croup have mild symptoms, and it is unknown whether they would derive the same degree of benefit from dexamethasone treatment as children with more severe disease.
                We conducted a double-blind trial at four pediatric emergency departments in which 720 children with mild croup were randomly assigned to receive one oral dose of either dexamethasone (0.6 mg per kilogram of body weight) or placebo. The children had mild croup, as defined by a score of < or =2 on the croup scoring system of Westley et al. The primary outcome was a return to a medical care provider for croup within seven days after treatment. The secondary outcome was the presence of ongoing symptoms of croup on days 1, 2, and 3 after treatment. Other outcomes included economic costs, hours of sleep lost by the child, and stress on the part of the parent in relation to the child's illness.
                Baseline clinical characteristics were similar in the two groups. Return to medical care was significantly lower in the dexamethasone group (7.3 percent vs. 15.3 percent, P<0.001). In the dexamethasone group, there was quicker resolution of croup symptoms (P=0.003), less lost sleep (P<0.001), and less stress on the part of the parent (P<0.001).
                For children with mild croup, dexamethasone is an effective treatment that results in consistent and small but important clinical and economic benefits. Although the long-term effects of this treatment are not known, our data support the use of dexamethasone in most, if not all, children with croup.
                Copyright 2004 Massachusetts Medical Society The objective of this study was to compare the efficacy of a single dose of oral dexamethasone of varying sizes in 120 children hospitalized with croup in two sequential double blind, randomized, controlled clinical trials (Trials A and B). The study was conducted in the Emergency Department Observation Ward of a tertiary pediatric hospital. One hundred and twenty children (age range 6 to 160 months) hospitalized with croup participated. Baseline characteristics for the two groups in each trial were similar. In Trial A 60 children received either 0.6 or 0.3 mg/kg dexamethasone syrup; in Trial B 60 children received either 0.3 or 0.15 mg/ kg dexamethasone syrup. Duration of hospitalization, reduction in croup scores, and adrenaline usage were evaluated. Median duration of hospitalization was similar for children in Trial A (7 and 8 hr), and in Trial B (9 and 9 hr). Croup scores following treatment did not differ and were significantly lower than initial scores for all groups and in each trial. Other outcome measures were similar for the two groups in each trial, including need for nebulized adrenaline, numbers of patients admitted to intensive care, rate of return to medical care with reoccurrence of croup, and readmission to hospital with croup following discharge from hospital. We conclude that oral dexamethasone in a dose of 0.15 mg/kg is as effective as 0.3 or 0.6 mg/kg in relieving symptoms and results in a similar duration of hospitalization in children with croup. 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.
                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.
                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).
                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. To determine whether a single dose of dexamethasone (0.6 mg/kg) is useful in the treatment of acute laryngotracheitis (croup), 29 hospitalized patients with acute laryngotracheitis were randomly assigned in a double-blind fashion to receive either parenterally administered dexamethasone (n = 16) or a saline placebo (n = 13). Severity of the illness was assessed by a clinical croup score based on retractions, stridor, air entry, cyanosis, and level of consciousness. Twelve hours from the time of injection, the patients receiving the dexamethasone had a statistically significant decline in median croup score from 4.5 to 1.0 (p less than 0.001), whereas the patients receiving the placebo did not. By 24 hours, a decline of two or more points in the total croup score was noted in 85% of the patients in the dexamethasone group compared with 33% of the patients in the placebo group (p = 0.027). During this same period, only 19% of patients receiving dexamethasone required two or more racemic epinephrine treatments in comparison with 62% of patients who received the placebo (p less than 0.05). There was no statistical difference between the two groups in improvement in oxygen saturation, respiratory rates, or duration of hospitalization. We conclude that dexamethasone is beneficial in reducing the overall severity of moderate to severe acute laryngotracheitis during the first 24 hours after injection. To compare the effectiveness of three corticosteroid regimens in children with mild to moderate croup.
                Double-blinded, randomized comparative trial with parallel design, conducted in the ED of a paediatric tertiary care hospital. Children aged 6 months to 6 years presenting to the ED with croup were eligible for inclusion if their Westley croup score was 2 or more. They were randomized to receive a single oral dose of either prednisolone 1 mg/kg, dexamethasone 0.15 mg/kg or dexamethasone 0.6 mg/kg. Primary outcome measures were the magnitude and rate of reduction in Westley croup score, rate of return for medical care with ongoing croup, and further treatment with steroids in the week following index presentation. Secondary outcome measures were the proportion of subjects requiring admission or salvage therapy, such as nebulized adrenaline, during index presentation.
                A total of 99 children, aged 6-79 months, were enrolled (mean age: 1.7 years). Thirty-four patients were randomized to receive prednisolone 1 mg/kg, 34 to receive dexamethasone 0.15 mg/kg, and 31 to receive dexamethasone 0.6 mg/kg. Baseline characteristics of the three groups were similar. The parents of 86 patients (87%) were available for follow-up telephone interview at 1 week. There were no significant differences in primary or secondary outcome measures between the three treatment groups.
                Both prednisolone 1 mg/kg and low-dose dexamethasone (0.15 mg/kg) were found not to differ in efficacy from the currently recommended 0.6 mg/kg dexamethasone. The use of these corticosteroid regimens in treating patients with mild to moderate croup is thus supported. Seventy-two children hospitalized for croup received on admission a single dose of either 0.6 mg/kg dexamethasone or an equivalent placebo intramuscularly from randomized ampules; subsequently the same patients were randomized to receive either nebulized racemic epinephrine or saline by intermittent positive pressure breathing. Of the four treatment groups those receiving a placebo injection and nebulized saline had the slowest recovery by all criteria. Dexamethasone and nebulized epinephrine reduced the symptoms and hastened recovery, but dexamethasone was more effective by clinical evaluation at 6 and 12 hours post admission. The patients given dexamethasone had a significantly shorter hospital stay than those receiving placebo. We conclude that a single injection of a potent corticosteroid is beneficial in acute spasmodic croup. Nebulized racemic epinephrine given with an appropriate device is also effective, but the effect of epinephrine is less remarkable in patients treated with dexamethasone. Nebulized budesonide and nebulized adrenaline have been shown to be effective in the treatment of moderately severe croup. However, there has been no direct comparison of these therapies. We undertook a multicenter, randomized, double-blind, parallel group study in 66 hospitalized children with viral or spasmodic croup.
                Children 0.5 to 6 years of age were assessed using a validated croup symptom score (stridor, 0 through 4; cough, 0 through 3; retractions, 0 through 3; dyspnea, 0 through 3; and color, 0 through 4) at 0.5, 1, 1.5, 2, 12, and 24 hours after nebulization. Patients received either budesonide (2 mg/4 mL) or L-adrenaline (4 mg/4 mL) via nebulization. The primary outcome measure was change in the total croup symptom score.
                Thirty-five children received budesonide and 31 received adrenaline. There was no significant difference in baseline features, including croup score (mean [95% confidence interval]: budesonide, 7.1 [6.7-7.5]; adrenaline, 7.7 [7.3-8.1]). All patients had significant improvement from baseline, and there was not significant difference between the two treatments, as measured by change in croup scores, change in oxygen saturation, duration of hospitalization, number of subsequent treatments with systemic steroids or adrenaline, and adverse events. No child required intubation.
                This study does not show any difference in efficacy and safety between nebulized budesonide and nebulized adrenaline in the treatment of acute upper airway obstruction in patients with moderately severe croup. In a randomized, controlled investigation, 349 children with pseudo-croup stage I or II were given 6 mg of dexamethasone or placebo. Although the rate of recovery was similar in both groups, there was a significant difference when only the more seriously affected children were considered: steroid treated patients recovered quicker. Steroids appear to be useful in the routine treatment of simple, uncomplicated pseudo-croup, even if their effect apparently is not very impressive. Thus, close supervision remains the most important measure in this nearly always benign but potentially dangerous condition. To evaluate the efficacy and safety of the topical corticosteroid budesonide, given in an oral controlled release formulation for maintenance of remission in patients with ileal and ileocaecal Crohn's disease (CD).
                Out of 176 patients with active CD who had achieved remission (CD activity index score < or = 150) after 10 weeks' treatment with either budesonide or prednisolone, 90 were randomised to continue with once daily treatment of 6 mg budesonide, or 3 mg budesonide or placebo for up to 12 months in a double blind, multicentre trial. Time to symptomatic relapse was calculated using Kaplan-Meier estimates. Morning plasma cortisol was measured at clinic visits and a corticotropin stimulation test was performed after three months of treatment.
                Thirty two patients were allocated to the 6 mg budesonide group, 31 to the 3 mg group, and 27 to the placebo group. After three months, 19 per cent of the patients in the 6 mg group had relapsed, compared with 45 per cent in the 3 mg group and 44 per cent in the placebo group (p = 0.047). The corresponding results after 12 months was 59 per cent in the 6 mg budesonide group, 74 per cent in the 3 mg group, and 63 per cent in the placebo group (p = 0.44). The median time to relapse or discontinuation was 258 days in the 6 mg group, 139 days in the 3 mg group, and 92 days in the placebo group (p = 0.021). Mean morning plasma cortisol values increased from entry in all three groups with no statistically significant differences at 12 months. All 13 patients remaining in the placebo group after three months had a normal corticotropin stimulation response, compared with 18 of 23 patients in the 6 mg, and 19 of 21 in the 3 mg budesonide groups (p = 0.14). Acne and moon face were slightly more common in the budesonide groups.
                6 mg budesonide once daily is significantly more efficacious than placebo in prolonging time to relapse in CD, and causes only minor systemic side effects. To assess the efficacy of oral dexamethasone or nebulized dexamethasone sodium phosphate in children with mild croup.
                Double-blind, placebo-controlled study of 264 children between 6 months and 6 years of age with symptoms of croup for fewer than 48 hours. Patients were excluded if they received racemic epinephrine or corticosteroid treatment. Other exclusion criteria included corticosteroid treatment during the 14 days prior to enrollment or complicating medical condition. Subjects randomly received oral dexamethasone (0.6 mg/kg), nebulized dexamethasone sodium phosphate (160 microg), or placebo. Telephone follow-up was obtained on days 1, 2, 3, 4, and 7.
                The primary outcome measure was treatment failure, defined as receiving corticosteroid or racemic epinephrine treatment during the 7 days after enrollment in the study. Secondary outcome measures included seeking additional care and the parental assessments of the patients' condition obtained during follow-up (worse, same, better, or gone).
                Eighty-five patients received oral dexamethasone, 91 received nebulized dexamethasone, and 88 received placebo. There were 3 treatment failures in the oral dexamethasone-treated group, 12 in the nebulized dexamethasone-treated group, and 10 in the placebo-treated group (P =.05). Ten children in the oral dexamethasone-treated group sought additional care compared with 27 and 29 in the nebulized dexamethasone-treated and placebo-treated groups, respectively (P =.002). Parents of children in the oral dexamethasone-treated group reported greater improvement on day 1 (P<.001) compared with the nebulized dexamethasone-treated and placebo-treated groups.
                Children with mild croup who receive oral dexamethasone treatment are less likely to seek subsequent medical care and demonstrate more rapid symptom resolution compared with children who receive nebulized dexamethasone or placebo treatment. Croup remains a common respiratory problem presenting to emergency departments. A single oral treatment of oral dexamethasone results in improved outcome. Prednisolone has similar pharmacokinetic properties and has a significant advantage in that it is commercially available in liquid preparations.
                To ascertain whether a single oral dose of prednisolone was equivalent to a single oral dose of dexamethasone (matched for potency) in children with mild to moderate croup.
                A double blind, randomised, controlled equivalence trial.
                Tertiary paediatric emergency department. Patients: 133 children aged 3 to 142 months presenting with mild to moderate croup.
                Children received either a single oral dose of dexamethasone 0.15 mg/kg or single oral dose of prednisolone 1 mg/kg. Outcome: The main outcome measure was unscheduled re-presentation to medical care as determined by telephone follow up at 7 to 10 days. Croup score, adrenaline (epinephrine) use, time spent in the emergency department, and duration of croup and viral symptoms were secondary outcome measures.
                Children treated with prednisolone were more likely to re-present: 19 of 65 children (29%) reattended medical care compared with 5 of 68 (7%) from the dexamethasone group. The confidence intervals around this 22% difference in outcome were 8% to 35%, outside the 0% to 7.5% range of equivalence. There were no significant differences in other outcome measures.
                A single oral dose of prednisolone is less effective than a single oral dose of dexamethasone in reducing unscheduled re-presentation to medical care in children with mild to moderate croup. To determine the effectiveness of a single dose of oral dexamethasone in reducing the pain associated with moderate to severe pharyngitis in pediatric patients.
                Prospective, randomized, double-blind, placebo-controlled clinical trial.
                Large, urban pediatric emergency department between March 2002 and November 2003.
                Children aged 5 to 18 years with moderate to severe pharyngitis (odynophagia or dysphagia, moderate to severe pharyngeal erythema or swelling, and a McGrath Facial Affective Scale score of 0.75 or higher [scale 0.0-1.0]).
                Study patients were randomly assigned to receive 1 dose of either oral dexamethasone suspension (0.6 mg/kg with a maximum of 10 mg) or placebo of the same volume. All participants were tested for group A beta-hemolytic streptococcal pharyngitis and treated accordingly. Daily telephone follow-up was conducted until complete resolution of sore throat.
                Primary outcome variables included hours to initial relief of sore throat and time to the complete resolution of pain. Secondary outcome variables included changes in the McGrath Facial Affective Scale score at 24 and 48 hours, persistence of associated symptoms, use of anti-inflammatory or antipyretic medication, and subsequent use of medical resources for dehydration or pain.
                A convenience sample of 150 patients was randomized to receive either dexamethasone (n = 75) or placebo (n = 75). Twenty-five patients were lost to follow-up, leaving 125 patients available for data analysis; 57 received dexamethasone and 68 received placebo. Patients who received dexamethasone reported earlier onset of pain relief (9.2 vs 18.2 hours; P<.001), fewer hours to complete resolution of sore throat (30.3 vs 43.8 hours; P = .04), and larger changes in the McGrath Facial Affective Scale score in the first 24 hours (-0.58 vs -0.43; P = .002). Children who tested negative for group A beta-hemolytic streptococci had greater pain relief with dexamethasone compared with placebo (onset of pain relief, 8.7 vs 24 hours; P = .001), less time to complete resolution of sore throat (37.9 vs 70.8 hours; P = .006), and greater changes in the McGrath Facial Affective Scale score in the first 24 hours (-0.50 vs -0.21; P<.001).
                Children with moderate to severe pharyngitis had earlier onset of pain relief and shorter duration of sore throat when given oral dexamethasone. The purpose of this study is to determine whether a single dose of dexamethasone 0.5mg/kg administered before surgery could decrease post operative vomiting and pain and improves oral intake in the first 24-hours after pediatric tonsillectomy procedures.
                It is a randomized, double blind, placebo controlled study. Sixty children age 2-12-years ASA 1 and 11 were scheduled for tonsillectomy, dexamethasone (n=29) and control group (n=31) were enrolled in the study. Dexamethasone group received 0.5mg/kg intravenous dexamethasone and control group received saline at the time of induction. The anesthetic regimen and surgical procedures were standardized for all patients. All patients were observed in post anesthesia care unit (PACU) and ward for post operative vomiting, pain, need for rescue antiemetic or analgesia and time for first oral intake for 24-hours.
                Data from 60 patients were analyzed. The overall incidence of early as well as late vomiting was significantly less in dexamethasone as compared to control group (37% versus 74% P=0.016), overall incidence of retching was 29% in control and 3.4% in dexamethasone (p=0.008). Vomiting once or more than once was significantly high in control as compared to dexamethasone group. The need for rescue antiemetic, the time to first oral intake and analgesic requirements did not show any significant difference in both groups.
                Dexamethasone is considered safe and there was no adverse effects associated with a single dose of dexamethasone. Although the need for rescue antiemetic, time to oral intake and analgesia requirements in both groups were not significant, however, we found that dexamethasone does have antiemetic properties as overall incidence of retching and vomiting was significantly less in dexamethasone group as compared to control group in children who underwent tonsillectomy. To determine whether dexamethasone prevents postextubation airway obstruction in young children.
                Prospective, randomized, double-blind, placebo-controlled study.
                Pediatric intensive care unit of a university teaching hospital.
                Sixty-six children, < 5 yrs of age, intubated and mechanically ventilated for > 48 hrs.
                Patients were randomized to receive intravenous dexamethasone (0.5 mg/kg, maximum dose 10 mg) or saline, every 6 hrs for six doses, beginning 6 to 12 hrs before elective extubation.
                Dependent variables included the presence of stridor, Croup Score, and pulsus paradoxus at 10 mins, 6, 12, and 24 hrs after extubation; need for aerosolized racemic epinephrine and reintubation. The dexamethasone and placebo groups were similar in age (median 3 months [range 1 to 57] vs. 4 months [range 1 to 59], p = .6), frequency of underlying airway anomalies (3/33 vs. 3/33, p = 1.0), and duration of mechanical ventilation (median 3.3 days [range 2.1 to 39] vs. 3.5 days [range 2.1 to 15], p = .7). The dexamethasone group had a lower frequency of stridor, Croup Score, and pulsus paradoxus measurement at 10 mins and at 6 and 12 hrs after extubation. Fewer dexamethasone-treated patients required epinephrine aerosol (4/31 vs. 22/32, p < .0001) and reintubation (0/31 vs. 7/32, p < .01). Three patients exited the study early-one patient in the dexamethasone group had occult gastrointestinal hemorrhage and one patient in each group had hypertension.
                Pretreatment with dexamethasone decreases the frequency of postextubation airway obstruction in children. To compare the effectiveness of nebulised L-epinephrine in combination with systemic or nebulised corticosteroid with that of cool mist and systemic corticosteroids in the treatment of moderate to severe croup. PATIENTS AND methods: Children were eligible for study if they presented to the emergency department with a moderate to severe croup. Patients were randomly assigned to three groups: group 1, cool mist and intramuscular dexamethasone (n = 26); group 2, nebulised L-epinephrine and intramuscular dexamethasone (n = 31); group 3, nebulised L-epinephrine and nebulised budesonide (n = 19). The croup score, vital signs and oxygen saturation were assessed before and after medication. Adverse events, additional L-epinephrine and hospitalisation were recorded.
                Age, sex, initial croup score and vital signs were similar in all groups. Croup scores were significantly decreased over time in all treatment groups and this decrease was very evident at 30 minutes (p < 0.05). Croup scores of groups 2 and 3 were significantly lower than those of group 1 at 30 and 60 minutes but no difference was observed between groups 2 and 3 at these timepoints. The numbers of patients who had croup scores <2 at 30 and 60 minutes were higher in groups 2 and 3 than group 1 (p = 0.004 and p = 0.032, respectively). More patients in group 1 received additional L-epinephrine treatments (p = 0.014). Changes in vital signs were not different among groups when assessed over time (p > 0.05).
                This study demonstrated that with early combination treatment, croup scores improved rapidly and hospitalisation rates were low. Patients with moderate to severe croup presenting to the emergency department should receive nebulised L-epinephrine in combination with intramuscular dexamethasone or nebulised budesonide. No significant adverse effects were observed with L-epinephrine. The use of L-epinephrine has been proposed instead of racemic epinephrine in patients with moderate to severe croup because it is efficacious, well tolerated, less expensive and more readily available in many countries. We compared the efficacy of high-dose dexamethasone sodium phosphate (0.6 mg/kg) in laryngotracheitis (LT) v spasmodic croup (SC) in 72 children (age range, 8 months to 8 years) using a double-blind randomized protocol that measured the individual change in respirations as an objective variable to evaluate the outcome. Administration of dexamethasone did not change the respirations in the patients with LT and significantly decreased the respirations in the patients with SC, compared with the placebo group. Since, in most cases, the pediatrician will be able to differentiate between LT and SC at admission by history and clinical signs, it seems that steroid treatment should be avoided in cases of LT and may be of benefit in some cases of SC. To compare early (<3 days) with late (>15 days) steroid therapy and dexamethasone with inhaled budesonide in very preterm infants at risk of developing chronic lung disease.
                Five hundred seventy infants from 47 neonatal intensive care units were enrolled. Criteria for enrollment included gestational age <30 weeks, postnatal age <72 hours, and need for mechanical ventilation and inspired oxygen concentration >30%. Infants were randomly allocated to 1 of 4 treatment groups in a factorial design: early (<72 hours) dexamethasone, early budesonide, delayed selective (>15 days) dexamethasone, and delayed selective budesonide. Dexamethasone was given in a tapering course beginning with 0.50 mg/kg/day in 2 divided doses for 3 days reducing by half until 12 days of therapy had elapsed. Budesonide was administered by metered dose inhaler and a spacing chamber in a dose of 400 microg/kg twice daily for 12 days. Delayed selective treatment was started if infants needed mechanical ventilation and >30% oxygen for >15 days. The factorial design allowed 2 major comparisons: early versus late treatment and systemic dexamethasone versus inhaled budesonide. The primary outcome was death or oxygen dependency at 36 weeks and analysis was on an intention-to-treat basis. Secondary outcome measures included death or major cerebral abnormality, duration of oxygen treatment, and complications of prematurity. Adverse effects were also monitored daily.
                There were no significant differences among the groups for the primary outcome. Early steroid treatment was associated with a lower primary outcome rate (odds ratio [OR]: 0.85; 95% confidence interval [CI]: 0.61,1.18) but even after adjustment for confounding variables the difference remained nonsignificant. Dexamethasone-treated infants also had a lower primary outcome rate (OR: 0.86; 95% CI: 0.62,1.20) but again this difference remained not significant after adjustment. For death before discharge, dexamethasone and early treatment had worse outcomes than budesonide and delayed selective treatment (OR: 1.42; 95% CI: 0.93,2.16; OR: 1.51; 95% CI: 0.99,2.30 after adjustment, respectively) with the results not quite reaching significance. Duration of supplementary oxygen was shorter in the early dexamethasone group (median: 31 days vs 40-44 days). Early dexamethasone was also associated with increased weight loss during the first 12 days of treatment (52 g vs 3 g) compared with early budesonide, but over 30 days there was no difference. In the early dexamethasone group, there was a reduced incidence of persistent ductus arteriosus (34% vs 52%-59%) and an increased risk of hyperglycemia (55% vs 29%-34%) compared with the other 3 groups. Dexamethasone was associated with an increased risk of hypertension and gastrointestinal problems compared with budesonide but only the former attained significance.
                Infants given early treatment and dexamethasone therapy had improved survival without chronic lung disease at 36 weeks compared with those given delayed selective treatment and inhaled budesonide, respectively, but results for survival to discharge were in the opposite direction; however, none of these findings attained statistical significance. Early dexamethasone treatment reduced the risk of persistent ductus arteriosus. Inhaled budesonide may be safer than dexamethasone, but there is no clear evidence that it is more or less effective. We present the results of a study designed to verify the efficacy of nebulized L-Adrenaline and/or dexamethasone given intramuscularly (IM) in the treatment of croup during childhood. Sixty-six children, hospitalized for croup during the period between october 1989 and september 1990, entered the study. They received the ordinary treatment with oxygen-therapy and fluid-therapy and were randomly assigned, in a double-blind fashion, into one of four treatment groups: Group 1: Nebulized L-Adrenaline and placebo (IM). Group 2: Nebulized saline and placebo (IM). Group 3: Nebulized saline and dexamethasone (IM). Group 4: Nebulized L-Adrenaline and dexamethasone (IM). The clinical evaluation was based on a scoring system assessing the inspiratory stridor, croupy cough, retractions and cyanosis. An analysis of variance was performed on the evolution of the score for two factors (Adrenaline and dexamethasone) to verify that there was no interaction between them. Subsequently, a one-factor analysis of variance was performed on the four treatment groups. We conclude that nebulized Adrenalin is more beneficial than saline in the clinical evolution of croup (p < 0.05). However, we did not find a statistically significant improvement in the group treated with dexamethasone when compared with the group treated with the placebo IM injection.
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.