ACTRN12616001213437已完成3 期
Ondansetron to reduce vomiting in children receiving intranasal fentanyl and inhaled nitrous oxide for procedural sedation: a double blind, randomised placebo controlled trial
Murdoch Children’s Research Institute0 个研究点目标入组 442 人开始时间: 2016年9月1日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 442
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 3 Years 至 18 Years（—）
- 性别
- All
入选标准
- •1. Be aged from 3 years to 18 years
- •2. Weight equal or greater than 15 kg
- •3. Planned procedural sedation with the combination of intranasal fentanyl and nitrous oxide
- •4. Have written informed consent provided by a parent or legal guardian. The participant may
- •also provide consent if he/she is deemed competent.
排除标准
- •1. Contraindication to receiving intranasal fentanyl: opioid allergy and acute/chronic nasal
- •2. Contraindication to receiving nitrous oxide as per institutional sedation manual
- •3. Contraindication to receiving ondansetron or placebo: known arrhythmia, use of QT-
- •prolonging drugs or allergy to any component of the ondansetron or placebo syrups
- •4. Cardiorespiratory instability
- •5. Decreased level of consciousness
- •6. Concomitant head injury
- •7. Planned use of additional sedatives
研究者
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