Migraine and High Flow Oxygenotherapy at the Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Pain evaluation
研究概览
简要总结
Migraine is a common pathology, affecting around 12% of the general population, up to 25% in some cohorts, as well as a significant part of the reasons for emergency room visits.
Unlike cluster headaches, the use of high-flow oxygen therapy has not yet been validated in patients with migraine.
However, several aspects of its pathophysiology, still studied to this day, suggest that the use of normobaric oxygen could have beneficial effects on migraine attacks: tissue hypoxia, cerebrovascular dysfunction with vasodilation, inflammation, etc.
In addition, high-flow oxygen therapy has no significant side effects and almost no contraindication (mainly COPD and other chronic respiratory failure) Its use in the event of a migraine attack would thus allow less recourse to conventional analgesics (with significant side effects for some), a shorter stay in the emergency room, and therefore a benefit in terms of cost and relief for the patient.
In this context, the sponsor wish to carry out a multicenter prospective interventional, single-blind randomized placebo-controlled in parallel groups study.
详细描述
Migraine is a common pathology, affecting around 12% of the general population, up to 25% in some cohorts, as well as a significant part of the reasons for emergency room visits.
Unlike cluster headaches, the use of high-flow oxygen therapy has not yet been validated in patients with migraine.
However, several aspects of its pathophysiology, still studied to this day, suggest that the use of normobaric oxygen could have beneficial effects on migraine attacks: tissue hypoxia, cerebrovascular dysfunction with vasodilation, inflammation, etc.
In addition, high-flow oxygen therapy has no significant side effects and almost no contraindication (mainly COPD and other chronic respiratory failure) Its use in the event of a migraine attack would thus allow less recourse to conventional analgesics (with significant side effects for some), a shorter stay in the emergency room, and therefore a benefit in terms of cost and relief for the patient.
In this context, the sponsor wish to carry out a multicenter prospective interventional, single-blind randomized placebo-controlled in parallel groups study.
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
- Single (Participant)
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
- •18 years old or more
- •Affiliated to a french public health insurance
- •ED admission for migraine evocative headache, regarding ICHD3 criterions
- •written informed consent
排除标准
- •COPD or other chronic respiratory failure conditions
- •Pregnant or breastfeeding women or women of childbearing potential not using any means of contraception. A pregnancy test will be performed for women of childbearing age. The results will be communicated to the patient by a doctor of her choice.
- •Under legal protection
- •Patients who have received treatment with triptan in the past 2 weeks
- •Patients who have consumed NSAIDs in the hour before the doctor's examination
- •State of migraine headache (crippling attack for more than 72 hours)
研究组 & 干预措施
oxygenotherapy
干预措施: oxygenotherapy (Drug)
placebo air aerosol
干预措施: placebo air aerosol (Drug)
结局指标
主要结局
Pain evaluation
时间窗: 30 minutes after aerosol started
Simple 0-10 pain verbal numerical rating scale (0 being the minimum : no pain, and 10 the maximum : worst pain imaginable by the subject)
次要结局
- Associated symptoms resolution(From aerosol start to 90 minutes after)
- Assess pain level(From 30 minutes after aerosol start to 90 minutes after)
- Occurrence of side effects(From aerosol start to ED exit assesed up to 6 hours, an average of 3 hours)
- Assessing time spent in emergencies(From ED admission to exit or transfert assesed up to 6 hours, an average of 3 hours)
- Rescue analgesics usage(From ED admission to exit or transfert assesed up to 6 hours, an average of 3 hours)