Use of the Methoxyflurane as Pain-killer in the Prehospital Management of Acute Myocardial Infarction
MAMI
2 other identifiers
interventional
700
1 country
1
Brief Summary
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2026
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2023
CompletedFirst Posted
Study publicly available on registry
March 3, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
March 3, 2026
February 1, 2026
3 years
February 13, 2023
February 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Demonstrate that methoxyflurane self-administered by the patient is at least as efficient in achieving pain relief that morphine
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)
at 30 minutes
Secondary Outcomes (9)
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 tolerance of the treatments on respiratory depression
at 30 minutes
- +4 more secondary outcomes
Study Arms (2)
Morphine
ACTIVE COMPARATORMorphine intra-venous infusion: 3 mg bolus repeated every 5 minutes until obtaining VAS ≤ 3
Methoxyflurane
EXPERIMENTALPatient's self-administration of methoxyflurane (Penthrox®) with dedicated inhaler Initial dose: 3 mL (1 vial). A second 3 mL dose can be used.
Interventions
Patient's self-administration of methoxyflurane (Penthrox®) with dedicated inhaler Initial dose: 3 mL (1 vial). A second 3 mL dose can be used. Treatment: from inclusion to hospital arrival.
Morphine intra-venous infusion: 3 mg bolus repeated every 5 minutes until obtaining VAS ≤ 3. Treatment: from inclusion to hospital arrival
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Avicenne
Bobigny, 93000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2023
First Posted
March 3, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
June 1, 2029
Study Completion (Estimated)
June 1, 2029
Last Updated
March 3, 2026
Record last verified: 2026-02