NCT00387556已完成不适用
Does Ondansetron Reduce the Incidence of Vomiting When Used in Conjunction With Ketamine During Procedural Sedation in the Pediatric Emergency Department
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- incidence of vomiting
研究概览
简要总结
Ondansetron, a commonly used anti-vomiting medication, may reduce the occurrence of vomiting associated with ketamine during procedural sedation in the pediatric emergency department.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Year 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 1-21 years, ASA I or II, fracture of dislocation reduction
排除标准
- •age < 1 year, ASA III or IV, hypertension, glaucoma, acute globe injury, increased intracranial pressure or central nervous system mass lesion, major psychiatric disorder, porphyria, previous adverse reaction to ketamine or ondansetron, parent, guardian or patient unwilling to provide informed consent.
研究组 & 干预措施
Ketamine + Ondansetron
Experimental
ketamine 1 mg/kg IV (maximum single dose 100 mg)+ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)
干预措施: Ondansetron (Drug)
Ketamine + Placebo
Placebo Comparator
ketamine 1 mg/kg IV (maximum single dose 100 mg)+2 ml normal saline solution IV (placebo
干预措施: Ondansetron (Drug)
结局指标
主要结局
incidence of vomiting
时间窗: Duration of ED stay and after discharge
The primary outcomes in this study were vomiting in the ED and after discharge, as determined by telephone follow-up
次要结局
- Length of ED stay(Duration of ED stay)
- Satisfaction with Sedation(Length of ED stay.)
研究者
研究点 (1)
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