2022-501133-23-00招募中2 期
Migraine and High Flow Oxygenotherapy at the Emergency Department (MiOx)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 5
- 主要终点
- 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.
研究概览
简要总结
To Study the effectiveness of high-throughput oxygen therapy on migraine attacks in emergency departments.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
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.
次要结局
- 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)
- Verbal Patient Pain Self-Assessment SLAs at 60 and 90 minutes (assess possible recurrence of pain)
- Frequency of occurrence of side effects
- Average time spent in emergency rooms
- Frequency of emergency painkillers
研究者
Julie CONTENTI
Scientific
Centre Hospitalier Universitaire De Nice
研究点 (5)
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