Dexamethasone Versus Prednisone for Asthma Treatment in the Pediatric Inpatient Population; a Feasibility Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Health Utilization
研究概览
简要总结
Current corticosteroid regimens for children hospitalized with asthma typically include a 5-day course of prednisone or prednisolone. However, these medications taste poorly and are associated with vomiting and poor compliance. Outpatient evidence suggests that a 2-day course of dexamethasone is as effective as a longer course of prednisone and prednisolone, and better tolerated. Studies in hospitalized patients are lacking.
The investigators' primary objective is to determine the feasibility of a non-inferiority trial, comparing 2 days of dexamethasone to 4 days of inpatient prednisone/prednisolone for inpatient asthma treatment. The investigators also wish to determine the feasibility of 1) enrolling patients upon admission to hospital, 2) asking patients and/or caregivers to complete a symptom weekly for 4 weeks, 3) reassessing patients post hospital discharge, 4) successfully completing phone follow up 4 weeks post hospital discharge, and 5) collecting health utilization data post hospital discharge.
This study will inform a future multi-site trial comparing prednisone/prednisolone to dexamethasone in inpatient asthma treatment. It has the potential of improving the delivery of care in asthma, by improving compliance with a mainstay of treatment. It will also enhance collaboration within Ontario pediatric hospitals, facilitating knowledge translation and standardization of care across institutions.
详细描述
- BACKGROUND AND RATIONALE 1.1 Background Information Summary of the problem Asthma is the most common childhood chronic disease, affecting over 15% of children between the ages of 4 and 11 years. In 2004, asthma contributed to 10% and 8% of all Canadian hospital admissions for children aged 0 to 4 years and 5 to 14 years, respectively. In Ontario, the burden of illness caused by asthma is enormous, accounting for one third of government expenditures for the general population.
A key element for treating children with acute asthma exacerbations is the administration of corticosteroids. Corticosteroids (CS) reduce the need for hospitalization and the risk of relapse after initial treatment, and may also facilitate an earlier discharge from the hospital.
While some hospitals already use a short course of dexamethasone for the inpatient asthma treatment, there is no evidence to support this practice in the inpatient population. Most current CS treatment regimens for the treatment of children hospitalized with an asthma exacerbation consist of a 5-day course of prednisone or prednisolone. However, prednisone and prednisolone are associated with poor taste and significant vomiting, as well as poor compliance with the treatment course. The lifetime prevalence of asthma in Canadian children has been estimated at 11% to 16% and asthma exacerbations are the leading cause of hospitalization in children. At the Children's Hospital of Eastern Ontario (CHEO), 215 children were admitted to the inpatient units for asthma in 2015, representing 5.4% of the yearly medical admissions.
Current corticosteroid standard of care for inpatient treatment of asthma CS are one of the cornerstones of therapy for acute asthma. They should be administered as early as possible in the Emergency Department (ED). Treatment with CS reduces the need for hospitalization, decreases the risk of relapse post treatment, and leads to a shorter length of stay. Current corticosteroid treatment regimens for the treatment of children hospitalized with an asthma exacerbation typically consist of a 4-day course of prednisone or prednisolone in addition to the dose of oral CS received in the ED.
Dexamethasone vs prednisone/prednisolone treatment A recent meta-analysis has shown that 2 days of once daily dexamethasone is a least as effective as 5 days of prednisone for preventing relapse in outpatient pediatric asthma. In addition, patients receiving dexamethasone were significantly less likely to experience vomiting in the ED and even after returning home. Preliminary cost-estimates suggest that dexamethasone may result in at least a $3500 cost savings per 100 patients compared to traditional treatment with prednisone or prednisolone. At CHEO, this would result in over $7000 in savings per year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children admitted during the study period with a diagnosis of asthma exacerbation,
- •Children aged 18 months to 17 years of age
- •Children who received oral Corticosteroids in the Emergency Department prior to admission under our hospital Emergency Department Nursing Medical Directive and/or Pre-Printed Order Form
排除标准
- •Children who received IV Corticosteroid (CS) in the Emergency Department (ED)
- •Children who received oral CS in the ED prescribed in any other way than through the Children's Hospital of Eastern Ontario ED Nursing Medical Directive and/or Pre-Printed Order Form as doses may not be standardized
- •Children who have received more than one dose of oral CS prior to enrolment
- •Children who have received their first dose of oral CS greater than 12 hours prior to enrolment
- •Children who received oral or IV CS in the previous 4 weeks
- •Children with any of the following: unrepaired congenital heart disease, chronic lung diseases other than asthma, severe neurological impairment and other significant co-morbid disorders as they are not typically treated on our hospital's asthma pathway
- •Children whose caregivers do not understand English or French
研究组 & 干预措施
Prednisone
Prednisone group: Children will receive four doses (days) of prednisone 1 mg/kg/dose once daily (maximum dose 50 mg) following the initial dose of corticosteroid received in the ED under the Nursing Medical Directive or Pre-Printed Order form.
干预措施: Prednisone (Drug)
Dexamethasone
Dexamethasone group: Children will receive the approximate pharmacologic equivalent of two doses (days) of dexamethasone 0.6 mg/kg/dose (maximum dose 16 mg per dose) once daily as follows. The standard dose of prednisone/prednisolone provided in the emergency department is 2 mg/kg/dose (maximum dose 50 mg), which is approximately equivalent to 0.3 mg/kg/dose of dexamethasone. Therefore, patients who received prednisone/prednisolone in emergency department as per the current Nursing Medical Directive and Pre-Printed Order form will receive a "top-up" These patients will then receive a dose of dexamethasone 0.6 mg/kg (maximum dose 16 mg) 24 hours after the initial corticosteroid dose received in the Emergency Department of dexamethasone 0.3 mg/kg (maximum dose 8 mg) upon enrollment.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Health Utilization
时间窗: 4 weeks
Readmission to hospital, repeat ED visit within 4 weeks for asthma, or unplanned visits to primary health care providers for asthma symptoms.
次要结局
- Allocation success(4 weeks)
- recruitment success(1 year)
- compliance with symptom reporting(4 weeks after discharge)
- Retention rate(4 weeks)
研究者
Catherine Pound
Consulting Paediatrician
Children's Hospital of Eastern Ontario