Methoxyflurane 99.9% for Acute Myocardial Infarction

Inclusion criteria

• {"criterion_text":"- Patient age ≥ 18 years\n- 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).\n- Patient managed in pre-hospital setting for a ST elevation myocardial infarction (STEMI): STEMI on ECG according to 2017 ESC guidelines"}

Exclusion criteria

• {"criterion_text":"- Previous analgesic treatment for this episode of chest pain\n- - Clinical evidence of cardiovascular instability (PAS <90 mm Hg)\n- Altered level of consciousness due to any cause, including head trauma, drug or alcohol use.\n- Clinically significant renal impairment.\n- History of signs of liver damage after use of methoxyflurane or after anesthesia with a halogenated hydrocarbon.\n- Severe hepatocellular insufficiency (with encephalopathy),,\n- Acute head trauma and intracranial hypertension in the absence of controlled ventilation,\n- Uncontrolled epilepsy\n- Treatment with buprenorphine, nalbuphine and pentazocine, naltrexone, nalmefene or sodium oxybate\n- Breastfeeding, in case of initiation or continuation after birth of a long-term treatment.\n- Malignant hyperthermia: known malignant hyperthermia or genetic predisposition of the patient.\n- Hypersensitivity to morphine, methoxyflurane, any fluorinated anesthetic or any of the excipients listed in SmPC\n- History of serious adverse effects of the patient or his family after administration of inhaled anesthetics.\n- Incapacity to self-assess pain intensity\n- Incapacity to methoxyflurane self-administration\n- Pregnancy, minors or incapacity (tutelle, curatelle)\n- Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants\n- Absence of a Social Security\n- Clinical evidence of respiratory depression.\n- Decompensated respiratory failure (in the absence of artificial ventilation),"}

Primary endpoints

• {"endpoint_text":"- Proportion of patients achieving pain relief, i.e. pain intensity score on visual analogic scale (VAS) ≤ 3 at 30 minutes.","definition_or_measurement_approach":"Pain intensity measured on visual analogic scale (VAS); proportion with VAS ≤ 3 at 30 minutes."}

Secondary endpoints

• {"endpoint_text":"- Pain relief: time before achieving pain relief, i.e. time between randomization and pain intensity score on VAS ≤ 3;","definition_or_measurement_approach":"Time between randomization and achievement of VAS ≤ 3."}
• {"endpoint_text":"- Pain relief: time to reach initial pain divided by two (initial VAS / 2)","definition_or_measurement_approach":"Time to reach a pain intensity equal to half of initial VAS (initial VAS / 2)."}
• {"endpoint_text":"- Impact of the treatments on cardiovascular system: heart rate, arterial blood pressure, pulse oximetry and ECG changes at hospital arrival","definition_or_measurement_approach":"Measurements of heart rate, arterial blood pressure, pulse oximetry and ECG changes at hospital arrival."}
• {"endpoint_text":"- Tolerance of the treatments: respiratory depression: respiratory rate < 10 cycles per minutes","definition_or_measurement_approach":"Respiratory rate monitoring; respiratory depression defined as respiratory rate < 10 breaths per minute."}
• {"endpoint_text":"- Tolerance of the treatments: sedation: Richmond Agitation - Sedation Scale (RASS) ≥ 2 or ≤ -2","definition_or_measurement_approach":"Sedation assessed by RASS; threshold RASS ≥ 2 or ≤ -2."}
• {"endpoint_text":"- Tolerance of the treatments: : dizziness, pruritus, nausea, vomiting, headache","definition_or_measurement_approach":"Recording of adverse symptoms: dizziness, pruritus, nausea, vomiting, headache."}

Methods

• Identification and enrolment in the pre-hospital setting by participating emergency medical services (SAMU) teams at listed French sites (patients managed in pre-hospital setting for STEMI).

France

Earliest CTIS Part Ii Submission Date

14-01-2026

Latest Decision Or Authorization Date

02-02-2026

Processing Time Days

19

Number Of Sites

10

Number Of Participants

700

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France