Transnasal Sphenopalatine Ganglia Block for Management of Chronic Migraines in Pediatric Patients
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Reduction in frequency of headache days: pre-treatment
研究概览
简要总结
Single-center, open-label, pre-post treatment pilot study to evaluate the safety and effectiveness of sphenopalatine ganglia blocks for the treatment of chronic migraine in the pediatric population. 50 children with a diagnosis of chronic migraines will undergo a series of three transnasal sphenopalatine ganglia blocks to measure their effect on headache frequency, headache intensity, headache duration, and use of headache medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ages 8 to 17 years old Meet the criteria for chronic migraines Have remained stable on their current headache medication for a minimum of 4 weeks.
- •Able to provide informed consent from parent or legal guardian Able to provide assent if subject is a minor of appropriate age
排除标准
- •Allergy to local anesthetic Developmental delay (e.g. non-verbal) Inability to use numeric pain scale Inability to perform or tolerate transnasal procedure Substance abuse disorders Known pregnancy
研究组 & 干预措施
Minors with chronic migraines
干预措施: Headache Journal (Other)
Minors with chronic migraines
干预措施: Sphenopalatine Block (Drug)
Minors with chronic migraines
干预措施: Tx360 (Device)
结局指标
主要结局
Reduction in frequency of headache days: pre-treatment
时间窗: Up to 4 weeks following consent
Weekly headache journal check in - 5 questions with y/n answers and free text entry
Reduction in frequency of headache days: post-treatment
时间窗: Up to one year following consent
Weekly headache journal check in - 5 questions with y/n answers and free text entry
次要结局
- Maximum headache severity: pre-treatment(up to 4 weeks following consent)
- Use of rescue medication: post-treatment(Up to one year following consent)
- Headache duration: pre-treatment(Up to 4 weeks following consent)
- Headache duration: post-treatment(Up to one year following consent)
- Maximum headache severity: post-treatment(up to one year following consent)
- Use of rescue medication: pre-treatment(Up to 4 weeks following consent)