Migraine
Conditions
Brief summary
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
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.
Interventions
DRUGoxygenotherapy
High concentration mask delivering 15L/min of oxygen
DRUGplacebo air aerosol
High concentration mask delivering 15L/min of air
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain evaluation | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rescue analgesics usage | From ED admission to exit or transfert assesed up to 6 hours, an average of 3 hours | The frequency of analgesics administration during patients stay |
| Associated symptoms resolution | From aerosol start to 90 minutes after | Associated symptoms (nausea, photophoby, neurological troubles ) resolution |
| Assess pain level | From 30 minutes after aerosol start to 90 minutes after | Simple 0-10 pain verbal numerical rating scale |
| Occurrence of side effects | From aerosol start to ED exit assesed up to 6 hours, an average of 3 hours | Evaluate the occurrence of side effects |
| Assessing time spent in emergencies | From ED admission to exit or transfert assesed up to 6 hours, an average of 3 hours | Patient stay in the ED duration |
Countries
France
Contacts
Primary ContactJulie CONTENTI
Backup ContactCéline OCCELLI
Outcome results
None listed