Comparison of Dexamethasone Oral Preparations to Assess Palatability and Adverse Effects in Children With Asthma and Croup
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Participants With Nausea
研究概览
简要总结
Study of the palatability and acceptability of dexamethasone oral tablets crushed and placed in apple sauce or pudding in comparison with the IV solution mixed with sugar syrup and given orally. It is hypothesized that dexamethasone tablets crushed and administered in apple sauce or pudding will be more palatable and acceptable for pediatric patients receiving dexamethasone for an acute asthma exacerbation or croup.
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
- 1 Year 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of acute asthma exacerbation or croup (laryngotracheitis) in the Vanderbilt Children's Hospital Emergency Department
- •Age 1 to 7 years
- •Dexamethasone treatment indicated
- •No other acute or chronic process accounting for signs and symptoms (e.g., foreign body aspiration, pneumonia, cystic fibrosis)
- •Have not received systemic corticosteroid for current episode prior to enrollment
排除标准
- •Allergy to dexamethasone or apple sauce and pudding
- •Unable to take medication orally
研究组 & 干预措施
Dexamethasone IV for PO
Dexamethasone IV for PO solution mixed with sugar syrup to be given orally
干预措施: Dexamethasone IV for PO (Drug)
Dexamethasone crushed tablets
Dexamethasone tablet crushed and placed in apple sauce or pudding to be given orally
干预措施: Dexamethasone crushed tablets (Drug)
结局指标
主要结局
Number of Participants With Nausea
时间窗: 1 hour
Presence of nausea after medication administration (yes/no) measured by participant self-report
次要结局
- Number of Participants Requiring Second Dose of Dexamethasone(1 hour)
研究者
Donald H Arnold
Professor of Pediatrics
Vanderbilt University Medical Center