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Not Yet RecruitingNCT07445737

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

Status
Not Yet Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
700 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGMethoxyfluranePatient'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.
DRUGMorphineMorphine intra-venous infusion: 3 mg bolus repeated every 5 minutes until obtaining VAS ≤ 3. Treatment: from inclusion to hospital arrival

Timeline

Start date
2026-06-01
Primary completion
2029-06-01
Completion
2029-06-01
First posted
2026-03-03
Last updated
2026-03-03

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT07445737. Inclusion in this directory is not an endorsement.