Comparison of 2 Application Techniques for LET (Lidocaine 4%; Epinephrine 0.1%; Tetracaine 0.5%) Gel Used Prior to Simple Laceration Repair in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Visual Analog Scale Pain Score
研究概览
简要总结
Comparison of anesthetic efficacy of Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel (LET) applied three times for 10 minutes each time vs. once for 30 minutes prior to suturing simple lacerations in children aged 7-17 years.
详细描述
Randomized single-blinded clinical trial with convenience sampling of the anesthetic efficacy of a single 30-minute application vs three 10-minute applications of Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel (LET) prior to suturing simple lacerations in children aged 7-17 years seen in the 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
- Double (Care Provider, Outcomes Assessor)
盲法说明
Investigator and nurse applied intervention and masked the intervention from the care provider. Separate nurse not caring for the patient, blinded to the intervention, brought in to obtain pain score (outcome)
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Simple <= 3cm lacerations requiring suturing (as decided by clinician care providers)
- •Plan to suture with simple interrupted sutures
排除标准
- •Lacerations involving the hands, feet, genitals, tongue, mucus membranes, nose, ears, or occurring over joints
- •Patients whose primary language was neither English nor Spanish
- •Developmentally delayed or disabled patient such that they were unable to give a pain score
- •Patients requiring procedural sedation or anxiolysis with oral or intranasal midazolam
研究组 & 干预措施
Single LET
One (single) application of LET topical gel [Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%)] applied for 30 minutes
干预措施: LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel (Drug)
Triple LET
Three applications of LET topical gel, one applied every 10 minutes
干预措施: LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel (Drug)
结局指标
主要结局
Visual Analog Scale Pain Score
时间窗: Immediately on placement or attempt at placement of first suture
Pain score self-rated by patient on 100m Visual Analog Pain scale, minimum value 0, maximum value 100, higher scores equal more pain (worse outcome)
次要结局
- Need for Additional Local Anesthetic(At any time during suturing procedure, time frame is duration of procedure, generally 10-20 minutes, less than one hour. Determined by chart review immediately after procedure completion.)
研究者
Kelly Young
Senior Physician
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center