Efficacy of Lidocaine as Local Anesthetics in Children Under Procedural Sedation and Analgesia Using Ketamine
试验速览
- 阶段
- 4 期
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Children's Hospital of Eastern Ontario Pain Scale (CHEOPS
研究概览
简要总结
Ketamine seems an obvious choice in the setting of an emergency department in laceration repair.
Lidocaine is the local anesthetics widespread used.
Ketamine leads to dissociative amnesia.
Theoretically , lidocaine is not useful in laceration repair using ketamine.
However, lidocaine is used with ketamine in many emergency department.
The investigators compare lidocaine with placebo as an adjunct to ketamine sedation in children undergoing primary closure
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
- 12 Months 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who need suturing for laceration under procedural anesthesia using ketamine
排除标准
- •contraindication to ketamine and lidocaine
- •patients involved to other studies
- •more or equal to American Society of Anesthesiologist (ASA) class III
- •not alert
研究组 & 干预措施
Normal saline
Normal saline will be used as a placebo for lidocaine
干预措施: Normal saline (Drug)
Lidocaine
Proper amount of lidocaine will be injected lacerated wound.
- dosage form: fluid
- dosage: not exceeding 1mg/kg
- frequency: once
- duration: n/a
干预措施: Lidocaine (Drug)
结局指标
主要结局
Children's Hospital of Eastern Ontario Pain Scale (CHEOPS
时间窗: up to 1 hour
The investigators will measure pain scale of sedated children with the CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) during suturing of lacerated wound.
次要结局
- Sedation scale(up to 1 hour)
- Complication(up to 1 hour)
- Satisfaction of parents and clinicians(up to 1 hour)
研究者
Jin Hee Lee
Assistant Professor
Seoul National University Hospital