Topical Intranasal Anesthetic Block for Reducing the Pain of Botulinum Toxin Injections for Chronic Migraine
2026年5月4日 更新者：Association of Migraine Disorders
Topical Intranasal Anesthetic Block for Reducing the Pain of Botulinum Toxin Injections for Chronic Migraine: A Randomized, Double-Blind, Placebo-Controlled Crossover Pilot Study
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).
研究概览
地位
招聘中
研究类型
介入性
注册 (估计的)
18
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Frederick A Godley, MD
- 电话号码：401-274-2300
- 邮箱：Rick@migrainedisorders.org
研究联系人备份
- 姓名：Leigh Serth
- 邮箱：Leigh@migrainedisorders.org
学习地点
-
-
Rhode Island
-
East Providence、Rhode Island、美国、02905
- 招聘中
- University Otolaryngology
-
接触：
- Frederick Godley III, MD
- 电话号码：401-274-2300
- 邮箱：rickgodley1@gmail.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Lidocaine
Intranasal 4% lidocaine: vial with 1ml solution with added flavor
|
The onabotulinumtoxinA prophylaxis procedure is the modified PREEMPT protocol consisting of 56 injections; 200 Units.
The solution from the vial (lidocaine) will be dripped onto 2 small pieces of cotton.
One piece of cotton will be placed in the anterior portion of the nasal cavity on each side of the nose.
The cotton will be removed after 5 minutes.
The clinician will then perform the various series of injections while assessing pain of the injection site following each series of injections.
|
|
安慰剂比较：Saline
Vial with 1ml liquid containing 0.9% sodium chloride solution with identical flavor
|
The onabotulinumtoxinA prophylaxis procedure is the modified PREEMPT protocol consisting of 56 injections; 200 Units.
The solution from the vial (Saline) will be dripped onto 2 small pieces of cotton.
One piece of cotton will be placed in the anterior portion of the nasal cavity on each side of the nose.
The cotton will be removed after 5 minutes.
The clinician will then perform the various series of injections while assessing pain of the injection site following each series of injections.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall patient-reported injection pain
大体时间：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.
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Immediately before and immediately following the procedure at Study Visit 1 and again 12 weeks later at Study Visit 2.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient-reported injection pain at each region
大体时间：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.
|
Comparison of patient-reported injection pain [0 (no pain) -10 (worse pain possible) Likert/Numeric Rating Scale] between regions by treatment. Facial anatomical regions include:
|
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.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Aurora SK, Winner P, Freeman MC, Spierings EL, Heiring JO, DeGryse RE, VanDenburgh AM, Nolan ME, Turkel CC. OnabotulinumtoxinA for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache. 2011 Oct;51(9):1358-73. doi: 10.1111/j.1526-4610.2011.01990.x. Epub 2011 Aug 29.
- Blumenfeld A, Silberstein SD, Dodick DW, Aurora SK, Turkel CC, Binder WJ. Method of injection of onabotulinumtoxinA for chronic migraine: a safe, well-tolerated, and effective treatment paradigm based on the PREEMPT clinical program. Headache. 2010 Oct;50(9):1406-18. doi: 10.1111/j.1526-4610.2010.01766.x.
- Comite S, Greene A, Cieszynski SA, Zaroovabeli P, Marks K. Minimizing discomfort during the injection of Radiesse with the use of either local anesthetic or ice. Dermatol Online J. 2007 Jul 13;13(3):5.
- Hamilton HK, Arndt KA. Techniques for minimizing pain with injections. J Am Acad Dermatol. 2013 Sep;69(3):e117. doi: 10.1016/j.jaad.2013.05.024. No abstract available.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年3月3日
初级完成 (估计的)
2027年1月1日
研究完成 (估计的)
2027年1月1日
研究注册日期
首次提交
2025年11月21日
首先提交符合 QC 标准的
2026年5月4日
首次发布 (实际的)
2026年5月6日
研究记录更新
最后更新发布 (实际的)
2026年5月6日
上次提交的符合 QC 标准的更新
2026年5月4日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.