2025-523349-86-00招募中3 期
MAMI Use of the Methoxyflurane as pain-killer in the prehospital management of Acute Myocardial Infarction
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 10
- 主要终点
- Proportion of patients achieving pain relief, i.e. pain intensity score on visual analogic scale (VAS) ≤ 3 at 30 minutes.
研究概览
简要总结
To demonstrate that methoxyflurane self-administered by the patient suffering chest pain related to an acute myocardial infarction is at least as efficient in achieving pain relief that morphine.
研究设计
- 分配方式
- Randomized
- 主要目的
- Mami
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patient age ≥ 18 years
- •Patient managed in pre-hospital setting for a ST elevation myocardial infarction (STEMI) : Chest pain < 12 hours with moderate to severe pain (VAS > 6/10).
- •Patient managed in pre-hospital setting for a ST elevation myocardial infarction (STEMI): STEMI on ECG according to 2017 ESC guidelines
排除标准
- •Previous analgesic treatment for this episode of chest pain
- •Clinical evidence of cardiovascular instability (PAS <90 mm Hg)
- •Altered level of consciousness due to any cause, including head trauma, drug or alcohol use.
- •Clinically significant renal impairment.
- •History of signs of liver damage after use of methoxyflurane or after anesthesia with a halogenated hydrocarbon.
- •Severe hepatocellular insufficiency (with encephalopathy),,
- •Acute head trauma and intracranial hypertension in the absence of controlled ventilation,
- •Uncontrolled epilepsy
- •Treatment with buprenorphine, nalbuphine and pentazocine, naltrexone, nalmefene or sodium oxybate
- •Breastfeeding, in case of initiation or continuation after birth of a long-term treatment.
- •Malignant hyperthermia: known malignant hyperthermia or genetic predisposition of the patient.
- •Hypersensitivity to morphine, methoxyflurane, any fluorinated anesthetic or any of the excipients listed in SmPC
- •History of serious adverse effects of the patient or his family after administration of inhaled anesthetics.
- •Incapacity to self-assess pain intensity
- •Incapacity to methoxyflurane self-administration
- •Pregnancy, minors or incapacity (tutelle, curatelle)
- •Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants
- •Absence of a Social Security
- •Clinical evidence of respiratory depression.
- •Decompensated respiratory failure (in the absence of artificial ventilation),
结局指标
主要结局
Proportion of patients achieving pain relief, i.e. pain intensity score on visual analogic scale (VAS) ≤ 3 at 30 minutes.
Proportion of patients achieving pain relief, i.e. pain intensity score on visual analogic scale (VAS) ≤ 3 at 30 minutes.
次要结局
- Pain relief: time before achieving pain relief, i.e. time between randomization and pain intensity score on VAS ≤ 3;
- Pain relief: time to reach initial pain divided by two (initial VAS / 2)
- Impact of the treatments on cardiovascular system: heart rate, arterial blood pressure, pulse oximetry and ECG changes at hospital arrival
- Tolerance of the treatments: respiratory depression: respiratory rate < 10 cycles per minutes
- Tolerance of the treatments: sedation: Richmond Agitation - Sedation Scale (RASS) ≥ 2 or ≤ -2
- Tolerance of the treatments: : dizziness, pruritus, nausea, vomiting, headache
研究者
Frédéric LAPOSTOLLE
Scientific
Assistance Publique Hopitaux De Paris
研究点 (10)
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