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Methoxyflurane vs Morphine for Prehospital Pain Management in STEMI

NCT07445737Phase 3

Key facts

Status: Not yet recruiting
Start: Jun 2026
Primary completion: Jun 2029
Countries: 1
Sponsor: Assistance publique - Hôpitaux de Paris
Modality: Allosteric Modulators

Drugs: methoxyflurane
Conditions: acute myocardial infarction (AMI)

Overview

Phase 3, randomised, open-label trial of methoxyflurane in acute myocardial infarction (AMI) (2 arms), sponsored by Assistance publique - Hôpitaux de Paris. Primary endpoint: Achievement of pain relief at 30 minutes. Planned start Jun 2026; status: not yet recruiting.

Design

2 arms

Study design: RandomizedOpen-label

Methoxyflurane
Patient's self-administration of methoxyflurane (Penthrox®) with dedicated inhaler Initial dose: 3 mL (1 vial). A second 3 mL dose can be used.
Morphine
Morphine intra-venous infusion: 3 mg bolus repeated every 5 minutes until obtaining VAS ≤ 3

Who it enrols

Adults with STEMI and moderate to severe chest pain (<12 hours) managed in a pre-hospital setting, excluding those with previous analgesic treatment, severe respiratory/renal/hepatic impairment, cardiovascular instability, or inability to self-administer methoxyflurane.

Endpoints

Primary

Achievement of pain relief30 minutes

Secondary

Impact on heart rate30 minutes
Impact on arterial blood pressure30 minutes
Impact on pulse oximetry30 minutes
Impact on ECG30 minutes
Tolerance on respiratory depression30 minutes
Tolerance on sedation30 minutes
Tolerance on dizziness, pruritus, nausea, vomiting, headache30 minutes
Time to first documented pain divided by twoup to 30 minutes

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