Use of the Methoxyflurane as Pain-killer in the Prehospital Management of Acute Myocardial Infarction

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

* 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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),

Trial design

Treatments tested in this trial

  • Methoxyflurane
  • Morphine

Treatment groups

700 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Medical Developments International Limited

Collaborator