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

ConditionSTEMI - ST Elevation 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Methoxyflurane

    Drug

    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

    Drug

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

Treatment groups

700 Participants
are divided into 2 treatment groups
Group A: MorphineActive comparator 1 intervention
Group B: MethoxyfluraneExperimental treatment 1 intervention

Trial outcomes

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)

Time frame
at 30 minutes

Secondary outcomes

1

Compare the impact of the treatments on heart rate

Impact of the treatments on cardiovascular system: heart rate (data collected every 5 minutes until to 30 minutes after randomisation and at hospital arrival)

Time frame
at 30 minutes
2

Compare the impact of the treatments on arterial blood pressure

Impact of the treatments on cardiovascular system: arterial blood pressure (data collected every 5 minutes until to 30 minutes after randomisation and at hospital arrival)

Time frame
at 30 minutes
3

Compare the impact of the treatments on pulse oximetry

Impact of the treatments on cardiovascular system: pulse oximetry (data collected every 5 minutes until to 30 minutes after randomisation and at hospital arrival)

Time frame
at 30 minutes
4

Compare the impact of the treatments on ECG

Impact of the treatments on cardiovascular system: ECG changes before discharge from the ambulance

Time frame
at 30 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Medical Developments International Limited

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: