Comparison of Outcome Between Dexamethasone Versus Prednisolone Administration in Acute Exacerbation of Childhood Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Asthma exacerbation
研究概览
简要总结
Because of insufficient local comparative data, this study was designed to determine the outcome of intravenous dexamethasone in contrast to oral prednisolone in acute exacerbation of asthmatic children.
详细描述
The findings of this study would furnish the local data. The results would also provide recommendations to use more appropriate steroid options in the local settings, resulting in aid to improve the quality of life of asthmatic children and their quicker return to daily routine activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of any gender
- •Aged 2-12 years
- •Presenting with acute exacerbation of asthma within 24-hours
排除标准
- •Children with PRAM score of ≥ 10
- •Used oral or parenteral corticosteroids in last 4-weeks
- •With any chronic condition of lungs (TB, cystic fibrosis), liver (chronic liver disease), kidneys (chronic kidney disease, nephrotic syndrome) or blood (thalassemia, malignancy)
研究组 & 干预措施
Intravenous Dexamethasone Group
Patients received a single IV dose of dexamethasone at a dose of 0.6 mg/kg.
干预措施: Dexamethasone (Drug)
Oral Prednisone Group
Patients were given oral prednisone at a dose of 2 mg/kg/day (max 60 mg) as a single dose for 3 days.
干预措施: Prednisolone (Drug)
结局指标
主要结局
Asthma exacerbation
时间窗: 4 days
The Pediatric Respiratory Assessment Measure (PRAM) score was used to assess the severity of asthma exacerbation. This score consisted of 5 items and had a maximum score of 12: suprasternal retractions (0-2), scalene muscle contraction (0-2), air entry in chest (0-3), wheeze (0-3), and oxygen saturation (0-2). A score of 1-3 showed mild exacerbation, 4-7 showed moderate exacerbation, and 8-12 revealed severe exacerbation of asthma.
次要结局
未报告次要终点
研究者
Muhammad Aamir Latif
Research Consultant
RESnTEC, Institute of Research