Pain Control for Laser Epilation in Pilonidal Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- David Mooney
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain related to laser follicle ablation
研究概览
简要总结
It's unclear if the application of topical lidocaine prior to laser follicle ablation is effective in reducing discomfort from the procedure. This study will use a doubly blinded case-control model to evaluate pain scores after the procedure comparing topical lidocaine to placebo.
详细描述
Patients presenting to a dedicated Pilonidal Care Clinic who have at least 2 future laser follicle ablations planned will be queried to determine their interest in participating in the study. Patients will be randomized to topical lidocaine or placebo, which will be applied for 30 minutes prior to the laser procedure, before which it will be removed. Laser technicians will be unaware of which cream the patient received and will record a post-procedure Likert pain score, from 0 to 10.
Patients will return in 6 to 8 weeks at which time they will crossover to the other group. Patients who received lidocaine cream will receive placebo and patients who received placebo will receive lidocaine cream. Cream removal and laser follicle ablation, with post-procedure pain score recording, will be conducted as during the first visit.
Twenty patients will be recruited and each patient will act as their own control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Cream will be applied by a clinician not involved in the laser procedure and will be removed prior to the procedure. Laser technicians will assess patient pain and will be blinded, as will the patient, to the study arm.
入排标准
- 年龄范围
- 16 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •undergoing laser follicle ablation for pilonidal disease and expected to need at least 2 more treatments -
排除标准
- •Unwilling to consent, not expected to need at least 2 more laser follicle ablations, not a candidate for laser
研究组 & 干预措施
Placebo
Sham cream placed and then removed prior to laser follicle ablation.
干预措施: Sham cream (Drug)
Active agent
Topical lidocaine cream placed and then removed prior to laser follicle ablation.
干预措施: Topical lidocaine (Drug)
结局指标
主要结局
Pain related to laser follicle ablation
时间窗: 5 minutes
Patient description on a Likert scale from 0 to 10 of the discomfort associated with the procedure.
次要结局
未报告次要终点
研究者
David Mooney
Associate Professor of Surgery
Boston Children's Hospital