NCT07445737尚未招募3 期
Use of the Methoxyflurane as Pain-killer in the Prehospital Management of Acute Myocardial Infarction
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Demonstrate that methoxyflurane self-administered by the patient is at least as efficient in achieving pain relief that morphine
研究概览
简要总结
- Chest pain is the main symptom of acute myocardial infarction. A precocious analgesic treatment is justified by patient's comfort and unfavorable hemodynamic consequences of persistent pain. Morphine is the painkiller historically prescribed in this situation. Morphine has never been evaluated vs placebo and is strongly suspected to decrease oral anti-platelet efficacy. Then, morphine has been downgraded, in the 2017 European guidelines (European Society of Cardiology - ESC) from I to IIa. To find alternative treatment is required.
- The methoxyflurane is an anesthetic gas used in emergency setting for about twenty years. It is now commonly used in France. Its analgesic properties have been demonstrated. Its main advantages are its maneuverability as it is delivered by inhalation, i.e. without (before) any venous access and self-administered by the patient. Tolerability is good. It could be an excellent alternative to morphine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 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) or STEMI on ECG according to 2017 ESC guidelines
排除标准
- •Previous analgesic treatment for this episode of chest pain
- •Hypersensitivity to morphine, methoxyflurane, any fluorinated anesthetic or any of the excipients listed in SmPC,
- •Decompensated respiratory failure (in the absence of artificial ventilation),
- •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.
- •Known malignant hyperthermia or genetic predisposition of the patient.
- •History of serious adverse effects of the patient or his family after administration of inhaled anesthetics.
- •History of signs of liver damage after use of methoxyflurane or after anesthesia with a halogenated hydrocarbon.
- •Clinically significant renal impairment.
- •Known renal failure with creatinine clearance below 30 ml/min or undergoing extracorporeal renal replacement therapy.
- •Altered level of consciousness due to any cause, including head trauma, drug or alcohol use.
- •Clinical evidence of cardiovascular instability (PAS <90 mm Hg).
- •Clinical evidence of respiratory depression.
- •Incapacity to self-assess pain intensity
- •Incapacity to methoxyflurane self-administration
- •Known pregnancy, breastfeeding, minors or incapacity (curatorship or guardianship)
- •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
研究组 & 干预措施
Morphine
Active Comparator
Morphine intra-venous infusion: 3 mg bolus repeated every 5 minutes until obtaining VAS ≤ 3
干预措施: Morphine (Drug)
Methoxyflurane
Experimental
Patient's self-administration of methoxyflurane (Penthrox®) with dedicated inhaler Initial dose: 3 mL (1 vial). A second 3 mL dose can be used.
干预措施: Methoxyflurane (Drug)
结局指标
主要结局
Demonstrate that methoxyflurane self-administered by the patient is at least as efficient in achieving pain relief that morphine
时间窗: at 30 minutes
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 with better tolerance (achieving pain relief, i.e. pain intensity score on visual analogic scale (VAS) ≤ 3 at 30 minutes)
次要结局
- Compare the impact of the treatments on heart rate(at 30 minutes)
- Compare the impact of the treatments on arterial blood pressure(at 30 minutes)
- Compare the impact of the treatments on pulse oximetry(at 30 minutes)
- Compare the impact of the treatments on ECG(at 30 minutes)
- Compare the impact of the treatments on pain relief(From randomization until the first documented pain relief, assessed up to 30 minutes)
- Compare tolerance of the treatments on respiratory depression(at 30 minutes)
- Compare tolerance of the treatments on sedation(at 30 minutes)
- Compare tolerance of the treatments on dizziness, pruritus, nausea, vomiting, headache(at 30 minutes)
- Compare the impact of the treatments on pain relief(From randomization until the first documented pain divided by two, assessed up to 30 minutes)
研究者
研究点 (1)
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