Comparative efficacy of oral dexamethasone with prednisolone in children with acute exacerbation of asthma
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in mean PRAM scores
研究概览
简要总结
Acute exacerbation contributes to the morbidity, mortality, poor quality of life and cost of asthma. Not much changes have been done in the standard treatment regimen hence therapeutic approaches need to be improved. Recent studies have shown that dexamethasone is a safer alternative to prednisolone and but the results regarding its use in emergency setting is inconclusive and their potential role in acute exacerbation has been unexplored. In this study, the patients will receive either dexamethasone or prednisolone and outcomes like length of hospital stay, PRAM score at admission, on day 4 and 6 hourly till the time of discharge, adverse effects, symptoms persisting at 7 days after admission, number of exacerbations requiring unplanned visits to hospital within 60 days of giving the medication, compliance, adverse effects experienced. And in case of any adverse effects if observed, patients will be immediately shifted to the standard regimen of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Children between the ages of 2 years to less than 18 years hospitalized with acute exacerbation of asthma.
排除标准
- •Life threatening exacerbation requiring PICU admissions.
- •Chronic comorbidities (e.g., congenital heart disease, immunodeficiencies).
- •Prior corticosteroid use in the last 30 days Children already enrolled in the study and presenting within 30 days of discharge from hospital.
结局指标
主要结局
Change in mean PRAM scores
时间窗: Baseline (admission) and day 4 of treatment
次要结局
- Duration of admission in emergency department(admission to discharge)
- Pediatric Respiratory Assessment Measure, measured 6 hourly till discharge or transfer from emergency department(6 hourly till discharge)
- Length of hospital stay(admission to discharge)
- Incidence of adverse effects(admission to discharge)
- Unscheduled visits to hospital due to symptoms of exacerbation asthma within 60 days of administration of steroids(discharge to 60 days after discharge)
- Persistence of symptoms after 7 days of discharge.(discharge till 7 days after discharge)
研究者
Dr Pryas Jain
Government medical college, Chandigarh