Topical Intranasal Anesthetic Block for Reducing the Pain of Botulinum Toxin Injections for Chronic Migraine: A Randomized, Double-Blind, Placebo-Controlled Crossover Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Overall patient-reported injection pain
研究概览
简要总结
People find the injections used in onabotulinumtoxinA (Botox®) uncomfortable. This study will test whether putting a small piece of cotton soaked with 4% lidocaine (a numbing medicine) inside the front of each nostril for 5 minutes before the injections reduces injection pain compared with cotton soaked in saline (salt water).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 years
- •Any gender
- •Able to provide informed consent
- •Meets clinical criteria for onabotulinumtoxinA for chronic migraine (minimum of 2 days of disability per month due to facial or headache pain, or 8 headache days per month, or more than 15 headaches per month)
- •Scheduled for modified PREEMPT injections at the clinical site
排除标准
- •Aged < 18 years
- •Trigeminal neuralgia, cluster headache, or other primary headache disorders as dominant diagnosis
- •Not able to provide informed consent
- •Known allergy/hypersensitivity to lidocaine or amide anesthetics
- •Pregnancy/lactation
- •Inability to tolerate intranasal nasal cotton pledgets
- •Significant nasal pathology at placement site
研究组 & 干预措施
Lidocaine
Intranasal 4% lidocaine: vial with 1ml solution with added flavor
干预措施: onabotulinumtoxinA prophylaxis with Lidocaine (Procedure)
Saline
Vial with 1ml liquid containing 0.9% sodium chloride solution with identical flavor
干预措施: OnabotulinumtoxinA prophylaxis with Saline (Procedure)
结局指标
主要结局
Overall patient-reported injection pain
时间窗: Immediately before and immediately following the procedure at Study Visit 1 and again 12 weeks later at Study Visit 2.
Overall patient-reported injection pain \[0 (no pain) -10 (worse pain possible) Likert/Numeric Rating Scale\] between 4% lidocaine versus 0.9% saline.
次要结局
- Patient-reported injection pain at each region(At Study Visit 1 and 12 weeks later at Study Visit 2. Ratings will occur within 1 minute of injection for each injection region during the procedure.)