Migraine and High Flow Oxygenotherapy at the Emergency Department (MiOx)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Migraine and High Flow Oxygenotherapy at the Emergency Department

Conditions
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Migraine

Intervention / Treatment
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* Drug: oxygenotherapy
* Drug: placebo air aerosol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old or more Affiliated to a french public health insurance ED admission for migraine evocative headache, regarding ICHD3 criterions written informed consent Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oxygenotherapy<br> | Drug: oxygenotherapy<br>* High concentration mask delivering 15L/min of oxygen<br>|
| Placebo Comparator: placebo air aerosol<br> | Drug: placebo air aerosol<br>* High concentration mask delivering 15L/min of air<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain evaluation | Simple 0-10 pain verbal numerical rating scale (0 being the minimum : no pain, and 10 the maximum : worst pain imaginable by the subject) | 30 minutes after aerosol started | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Associated symptoms resolution | Associated symptoms (nausea, photophoby, neurological troubles ) resolution | From aerosol start to 90 minutes after | 
| Assess pain level | Simple 0-10 pain verbal numerical rating scale | From 30 minutes after aerosol start to 90 minutes after | 
| Occurrence of side effects | Evaluate the 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 | Patient stay in the ED duration | From ED admission to exit or transfert assesed up to 6 hours, an average of 3 hours | 
| Rescue analgesics usage | The frequency of analgesics administration during patients stay | From ED admission to exit or transfert assesed up to 6 hours, an average of 3 hours |