Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- OSBD-r
研究概览
简要总结
There are multiple retrospective studies detailing the use of etomidate in pediatric procedural sedation but few to no prospective clinical trials. None have compared etomidate to ketamine, currently the most commonly used sedative in the emergency department for pediatric procedural sedation. The investigators propose a randomized, controlled trial comparing etomidate versus ketamine for procedural sedation for fracture reduction for children presenting with extremity fracture requiring sedation for reduction. The investigators hypothesize that etomidate in combination with fentanyl will have similar reduction of distress and procedural recall as ketamine in combination with midazolam.
详细描述
There are multiple retrospective studies detailing the use of etomidate in pediatric procedural sedation but few to no prospective clinical trials. None have compared etomidate to ketamine, currently the most commonly used sedative in the emergency department for pediatric procedural sedation. The investigators propose a randomized, controlled trial comparing etomidate versus ketamine for procedural sedation for fracture reduction for children presenting with extremity fracture requiring sedation for reduction. The investigators hypothesize that etomidate in combination with fentanyl will have similar reduction of distress and procedural recall as ketamine in combination with midazolam.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 5-18 years
- •extremity fracture requiring reduction with sedation in emergency department
排除标准
- •allergy to etomidate, midazolam, fentanyl, ketamine, lidocaine
- •multi-system trauma
- •history of psychosis
- •pregnancy
- •illicit drug use
- •developmental delay
- •non-english speaker
研究组 & 干预措施
ketamine and midazolam
ketamine and midazolam
干预措施: ketamine and midazolam (Drug)
etomidate and fentanyl and lidocaine
etomidate and fentanyl and lidocaine
干预措施: etomidate, fentanyl, and lidocaine (Drug)
结局指标
主要结局
OSBD-r
时间窗: immediate
Outcome measures included guardian and staff completion of visual analog scale and Likert scales for observed pain and satisfaction, blinded OSBD-r (Observational Scale of Behavioral Distress-Revised) scoring of digital recordings of reductions, and sedation and recovery times.
次要结局
- Likert satisfaction scale(immediate)
- procedural recall(immediate)