A randomized double-blind, placebo-controlled trial of dexamethasone and racemic epinephrine in the treatment of croup

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 racemic epinephrine by IPPB for the treatment of croup: a double-blind study.

Racemic epinephrine has been advocated for the treatment of croup, but controlled studies have not proved it more effective than saline. Twenty patients (aged 4 months to 5 years) hospitalized with acute croup and persistent inspiratory stridor at rest were randomly assigned to one of two treatment groups: saline or racemic epinephrine, both nebulized and delivered by intermittent positive pressure breathing. Clinical scores were significantly improved (P less than .01) at ten and 30 minutes following the treatment with racemic epinephrine but not at 120 minutes. Racemic epinephrine was significantly more effective than saline at 10 (P less than .01) and 30 minutes (P less than .05) but not at 120 minutes after the treatment. We conclude that nebulized racemic epinephrine is effective treatment for the acute signs of croup.     

Simple nebulization of racemic epinephrine in the treatment of acute laryngitis (croup) (author's transl)

Five infants with acute laryngitis (croup) were treated with nebulized racemic epinephrine. In contrast to previous reports the mist was not delivered by intermittent positive pressure ventilation via a respirator but by simple inhalation via a jet-type nebulizer and face mask. Immediate though only transitory relief of symptoms without any significant alteration of heart rate was achieved by low doses of the diluted drug. Increase in dosage resulted in a moderate elevation of heart rate without improvement in therapeutic action. Inhalations had to be repeated frequently; there were no significant side effects of treatment. Altogether the observed therapeutic actions resembled the reported effects of nebulized epinephrine delivered by intermittent positive pressure ventilation.     

A prospective randomized double-blind study to evaluate the effect of dexamethasone in acute laryngotracheitis

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.     

Prospective randomized controlled study comparing low-cost LED and conventional phototherapy for treatment of neonatal hyperbilirubinemia

Our objective was to carry out a prospective, randomized, single-blind study to evaluate whether light emitting diode (LED) phototherapy using a low-cost set of lights is as effective as conventional phototherapy in treating hyperbilirubinemia in neonates. The study included 45 pre-term neonates requiring phototherapy as per American Academy of Pediatrics guidelines; participants were randomized to receive phototherapy using LED-based lights, conventional fluorescent blue lights or conventional halogen lights. There were no statistically significant differences in the average bilirubin levels at the onset, at the maximum and at the end of treatment, nor in the duration of phototherapy treatment and the rate of decrease in bilirubin levels in the neonates receiving conventional fluorescent blue light, conventional halogen light and LED phototherapy. (Differences were considered significant at p?相似文献   

A prospective randomized study to determine the efficacy of steroids in treatment of 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.     

Prospective one-year epidemiologic longitudinal study of air pollutants and the incidence of croup

Among a population of 18,175 children below 7 years of age in medium sized towns and rural areas in south-western Germany 552 (3.03%) cases of croup were registered during a 12 months period in 1984-85 by their physicians. Distributions according to months, sex and age at the onset of the disease were the same as in other recent investigations: The level of the air-pollution measured (SO2, NOx, CO, CO2, ozone and dust) was low (highest monthly means in microgram/m3: SO2 88, NO2 73, NO 119, dust 41). There was no relevant influence of the degree of air pollution on croup-frequency. The rise of croup-frequency shortly after a period of several days of higher pollution was accompanied by an influenza epidemic as proved by virus isolations.     

A prospective,randomized, double-blind study comparing the efficacy of diltiazem,glyceryl trinitrate,and lidocaine for the treatment of anal fissure in children

Purpose  

Anal fissure (AF) is a common perianal condition in children. Although adult patients with AF have been treated successfully using diltiazem, it has not been studied in children. The present randomized, prospective, double-blind study assessed the response, side effects, and recurrence of diltiazem.     

Steroid treatment of laryngotracheitis: a meta-analysis of the evidence from randomized trials

The use of adrenocorticoids to reduce the morbidity associated with laryngotracheitis (croup) remains controversial despite ten published reports of randomized trials involving 1,286 patients. To determine whether, viewed in aggregate, these studies demonstrate a significant benefit of steroid treatment for this disorder, a meta-analysis of the nine methodologically satisfactory trials was performed. Clinical improvement 12 and 24 hours posttreatment and incidence of endotracheal intubation were evaluated. For each end point, an estimate of the overall effect was obtained by calculating a typical odds ratio and 95% confidence interval. This analysis indicates that the use of steroids in children hospitalized with croup is associated with a significantly increased proportion of patients showing clinical improvement 12 hours (odds ratio = 2.25, 95% confidence interval = 1.66, 3.06) and 24 hours (odds ratio = 3.19, 95% confidence interval = 1.70, 5.99) posttreatment and a significantly reduced incidence of endotracheal intubation (odds ratio = 0.21, 95% confidence interval = 0.05, 0.84). Higher initial doses of steroid (greater than or equal to 125 mg of cortisone or greater than or equal to 100 mg of hydrocortisone) were associated with a larger proportion of patients improved 12 hours posttreatment than was seen with lower doses. These results support the use of steroids in the treatment of hospitalized children with croup and, in the absence of a randomized clinical trial of sufficient size, provide the most reliable estimate of the impact of steroid therapy on the morbidity associated with croup. In addition, the results of this meta-analysis may be used to estimate the number of subjects who would be required to conduct a randomized clinical trial of steroids for the treatment of croup.     

Effect of racemic epinephrine on ventilatory function in the neonate postextubation

The use of nebulized racemic epinephrine to improve ventilatory function in the newborn postextubation was studied. Forty-five infants intubated for more than 3 days were randomized to receive racemic epinephrine by nebulization immediately postextubation or to receive only warmed, humidified gas. Measurements of air flow, esophageal pressure, tidal volume, respiratory rate, and heart rate were made before treatment and every 10 min for 1 h after treatment. Resistance was calculated from recorded data. Changes from baseline values were calculated for each time period. Analysis of variance of these variables for treatment, sex, and time main effects and their interactions, with appropriate adjustments for covariables, was performed. Although some sex interactions were seen, there were no significant time effects or interactions. This study provides no evidence that using nebulized racemic epinephrine in infants postextubation improves ventilatory function.     

Inhalation of racemic adrenaline in the treatment of mild and moderately severe croup. Clinical symptom score and oxygen saturation measurements for evaluation of treatment effects

The aim of this study was to evaluate the immediate effect of inhaling racemic adrenaline to treat croup and to evaluate a scoring system. Two groups were investigated. One group inhaled a racemic adrenaline solution and the other group received the same solution with no racemic adrenaline. The study was double-blinded and placebo-controlled. Fifty-four children (0.4–10.8 years) with mild to moderately severe croup were included in the study after clinical evaluation. The clinical score was useful when evaluating the treatment effects in mild to moderately severe croup and may be used as a quality assurance tool when treatment protocols are re-evaluated. Oxygen saturation before and after treatment did not change significantly in either group and therefore its measurement did not provide additional information on the effect of treatment. In both groups, a significant improvement in total mean clinical scores was seen 30 min after inhalation, compared with before inhalation (p < 0.001). However, racemic adrenaline was significantly better than placebo in terms of improvement in total clinical score, inspiratory stridor, retractions and air entry, and should therefore be used as first-line treatment.     

A double-blind study comparing the effectiveness of cromolyn sodium and sustained-release theophylline in childhood asthma

The effectiveness of cromolyn sodium and theophylline on asthma in children was compared during a 3-month trial. Forty-six children (aged 5 to 15 years) with asthma were assigned at random to cromolyn or theophylline (Theo-Dur) treatment groups. Each subject received theophylline placebo or cromolyn placebo in addition to the active drugs. A methacholine challenge test was done at the start of the study to document asthma and was repeated during the third month. The theophylline dosage was regulated to obtain serum levels of 10 to 15 micrograms/mL by a physician not involved directly with patient care. Forty patients completed the study. Both theophylline and cromolyn treatment groups showed improvement from base-line status in terms of symptom scores, pulmonary function, and decreased use of inhaled albuterol. Patients treated with theophylline had more side effects and required more frequent office visits than those treated with cromolyn. Both groups had decreased sensitivity to methacholine, and for one statistical test patients treated with cromolyn improved significantly. These results indicate that cromolyn is as effective as theophylline in treating mild to moderate asthma in children; additional benefits were fewer side effects and a possible decrease in bronchial hyperactivity.     

Prospective epidemiological study of rotavirus gastroenteritis in Europe (REVEAL study). Results in the French area of the study]

PRIMARY OBJECTIVE: To estimate the incidence of acute gastroenteritis (AGE) and rotavirus acute gastroenteritis (RVAGE) in children less than 5 years of age seeking medical care in primary care, emergency department, and hospital settings. SECONDARY OBJECTIVES: To compare the clinical profile of RVAGE and non-RVAGE and to describe the distribution of RV serotypes among RVAGE cases. METHODS: A prospective primary care, emergency ward and hospital-based observational study was conducted during 1 year in a selected city of France with 250,000 inhabitants. Children less than 5 years of age presenting with symptoms of AGE were included. Rotavirus was identified using an Elisa test in stools. RESULTS: The estimated annual incidence of RVAGE was 1.56% for AGE and 0.87% for RVAGE in hospital, 5.87% for AGE and 2.65% for RVAGE in emergency-wards, 7.39% for AGE and 1.45% for RVAGE in primary care. Total incidence was 14.82% for AGE and 4.96% for RVAGE among children less than 5 years of age. RVAGE were more clinically severe than the AGE: dehydration (26.8% vs. 14.7%, p<0.0001), vomiting 84.9% vs. 60.9%, p<0.0001), fever (74.3% vs. 44.4%, p<0.0001), lethargy (84.9% vs. 70.2%, p<0.0001). G9 serotype was the most frequent serotype encountered (54.7%) during the study period followed by G3 serotype (33.6%) and G2 serotype (7.9%). CONCLUSION: In this study, RVAGE, caused by serotypes G9 and G3, represented about 1/3 of AGE and were more severe than non-RV AGE with twice as high dehydration rate. These results underline the need for continued promotion on the use of oral rehydration fluids and provide some arguments on the benefits of vaccination against rotavirus and also permanent virological monitoring of circulating serotypes.