Lidocaine Versus Diphenhydramine to Achieve Local Anesthesia for Laceration Repairs
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Sensation reduction
研究概览
简要总结
Diphenhydramine, when injected locally, has been shown to achieve a certain level of local anesthesia. It has been documented for use in simple bedside procedures, however there is a gap in knowledge in its comparison to lidocaine. The purpose of the study is to determine if local infiltration of diphenhydramine is noninferior to the use of lidocaine 1% when trying to achieve local anesthesia for simple laceration repair. Patients who present to the emergency department with a simple laceration will be enrolled in the study. Patients will be evaluated for the pain of the injection as well as the pain of the laceration repair procedure post injection.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Lacerations requiring one layer of sutures
- •Lacerations appropriate for repair by emergency physicians
排除标准
- •Active bleeding from laceration
- •Complex lacerations requiring multiple layers
- •Lacerations to be repaired by a specialist service
- •Patients with allergies to either diphenhydramine or lidocaine
- •Laceration repairs would benefit from the use of epinephrine as an additive to the local anesthetic
研究组 & 干预措施
Lidocaine
干预措施: Lidocaine (Drug)
Diphenhydramine
干预措施: Diphenhydramine (Drug)
结局指标
主要结局
Sensation reduction
时间窗: Measurements will be recorded before drug injection and immediately after laceration repair.
Participants will rate their sensation level on a visual analog scale from 0 to 10 both before the drug injection and after the laceration repair procedure. 0 indicating no sensation and 10 indicating worst sensation. Reduction in sensation will be calculated as the difference between the pre-injection and post-procedure sensation, with a larger number indicating a greater reduction in sensation.
次要结局
- Anesthesia satisfaction by patient(Immediately after laceration repair)
- Anesthesia satisfaction by physician(Immediately after laceration repair)