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

Phase 1

Recruiting

Conditions: MIGRAINE
MedDRA version: 21.1Level: LLTClassification code: 10010108Term: Common migraine Class: 10029205
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: CTIS2022-501133-23-00

Lead Sponsor: Centre Hospitalier Universitaire De Nice

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

Patients 18 years of age or older, Admitted to the emergency department for migraine-evocative headache according to the criteria of the International Classification of Headaches 3rd edition ICHD-3, Written consent to participate after being informed of the study, Pain intensity at least equal to 6 assessed by the patient’s verbal pain self-assessment

Exclusion Criteria

Patients with risk of respiratory failure by hypercapnia (COPD, cystic fibrosis, morbid obesity, malformation of the chest wall, neuromuscular disorder), Patients under legal protection, Patients treated with triptan in the last 2 weeks, Patients who consumed NSAIDs in the hour prior to physician review, Disabling migraine crisis during for more than 72 hours, History of paraquat poisoning, History of treatment with amiodarone, bleomycin or nitrofurantoin

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To Study the effectiveness of high-throughput oxygen therapy on migraine attacks in emergency departments.;Secondary Objective: Evaluate the effectiveness of high-throughput oxygen therapy on any associated symptoms (such as nausea, photophobia, neurological disorders), Assess possible recurrence of pain at 60 and 90 minutes, Evaluate the occurrence of side effects, Evaluate the time spent in emergency rooms, Evaluating the use of relief analgesics;Primary end point(s): PProportion of subjects with a score less than or equal to 3 on the Simple Numerical Scale (SLA) of verbal self-assessment of patient pain (0-10), 30 minutes after the start of inhaled treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Disappearance of any associated symptoms (nausea, photophobia, etc.): frequencies at t=0, 30, 60 and 90 minutes after the start of the oxygen or placebo session (air);Secondary end point(s):Verbal Patient Pain Self-Assessment SLAs at 60 and 90 minutes (assess possible recurrence of pain);Secondary end point(s):Frequency of occurrence of side effects;Secondary end point(s):Average time spent in emergency rooms;Secondary end point(s):Frequency of emergency painkillers