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Study on Methoxyflurane for Pain Relief in Patients with Heart Attack

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness of a medication called methoxyflurane in managing pain for patients experiencing an Acute Myocardial Infarction, commonly known as a heart attack. The study will compare methoxyflurane to another pain relief medication, morphine, to see if methoxyflurane can provide similar pain relief with better tolerance. Methoxyflurane is administered through inhalation, while morphine is given as an intravenous bolus, which means it is injected directly into a vein.

The purpose of the study is to determine if methoxyflurane, when self-administered by patients, can effectively relieve chest pain associated with a heart attack. Participants in the study will receive either methoxyflurane or morphine to manage their pain. The study will monitor how quickly and effectively each medication relieves pain and will also assess the impact on the cardiovascular system, including heart rate and blood pressure, as well as any side effects such as dizziness, nausea, or respiratory issues.

The trial will take place in a pre-hospital setting, meaning it will be conducted before patients reach the hospital. The study aims to provide valuable information on whether methoxyflurane can be a viable alternative to morphine for pain management in heart attack patients, potentially offering a more comfortable experience with fewer side effects. The trial is expected to run until 2028, with recruitment starting in 2025.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be informed about the purpose of the study, which is to evaluate the effectiveness of methoxyflurane as a pain reliever compared to morphine for chest pain related to an acute heart attack.

    You will be asked to provide consent to participate in the study, confirming your understanding and willingness to be part of the trial.

  2. Step 2

    Eligibility confirmation

    Your eligibility will be confirmed based on criteria such as being 18 years or older and experiencing chest pain due to a specific type of heart attack known as ST elevation myocardial infarction (STEMI).

    The pain should have started less than 12 hours ago and be moderate to severe, with a pain score greater than 6 out of 10.

  3. Step 3

    Randomization and treatment

    You will be randomly assigned to receive either methoxyflurane or morphine for pain relief.

    Methoxyflurane will be self-administered through inhalation, using a liquid form that turns into vapor. Morphine will be given as an intravenous bolus, which means it is injected directly into a vein.

  4. Step 4

    Monitoring and assessment

    Your pain levels will be monitored using a visual scale, aiming to reduce your pain score to 3 or less within 30 minutes.

    Additional assessments will include measuring heart rate, blood pressure, and other vital signs to evaluate the impact of the treatment on your cardiovascular system.

  5. Step 5

    Evaluation of treatment tolerance

    The study will also assess how well you tolerate the treatment, checking for any side effects such as dizziness, nausea, or changes in breathing.

    Your level of alertness will be monitored using a scale to ensure you remain comfortable and safe during the trial.

Who can join the trial?

6 criteria

  • Patient must be 18 years or older.
  • Patient must be experiencing a ST elevation myocardial infarction (STEMI), which is a type of heart attack, and must be managed in a pre-hospital setting.
  • Patient must have chest pain lasting less than 12 hours with moderate to severe intensity, which means a pain score of more than 6 out of 10.
  • Patient must have a STEMI confirmed on an EKG (a test that checks the heart's electrical activity) according to the 2018 guidelines from the European Society of Cardiology (ESC).
  • Both male and female patients can participate.
  • Patients who are considered part of a vulnerable population are not included.

Who cannot join the trial?

3 criteria

  • Patients who have had an acute myocardial infarction (a heart attack) cannot participate.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.
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Investigated drugs

  • Methoxyflurane

    is a medication used to relieve pain. In this trial, patients who are experiencing chest pain due to a heart attack will use methoxyflurane to see if it can help reduce their pain. The unique aspect of this medication is that it can be self-administered, meaning the patient can control when and how much they use it to manage their pain. The goal is to see if methoxyflurane can provide pain relief that is as effective as another pain medication, with fewer side effects.

  • Morphine

    is a well-known pain medication often used in hospitals to treat severe pain, including pain from a heart attack. In this trial, morphine is used as a comparison to see if methoxyflurane can provide similar pain relief. Morphine is typically given by healthcare professionals and works by changing the way the brain and nervous system respond to pain, helping to make the pain feel less intense.

What is already known about the treatment

Methoxyflurane – Methoxyflurane is administered through inhalation, allowing patients to self-administer the medication using a special device to manage pain. It is currently being studied for its effectiveness in relieving chest pain in patients experiencing an acute myocardial infarction, commonly known as a heart attack. The main therapeutic use of methoxyflurane in this context is to provide pain relief with potentially better tolerance compared to traditional painkillers like morphine. At the molecular level, methoxyflurane works by affecting the central nervous system to reduce the sensation of pain. It is classified pharmacologically as an inhaled analgesic, which means it is a pain-relieving medication that is inhaled.

Investigated diseases

Acute Myocardial Infarction – Acute Myocardial Infarction, commonly known as a heart attack, occurs when blood flow to a part of the heart is blocked for a long enough time that part of the heart muscle is damaged or dies. This blockage is often due to a buildup of fat, cholesterol, and other substances, which form a plaque in the coronary arteries. As the plaque breaks, a blood clot forms, which can completely block the blood flow. The affected heart muscle becomes deprived of oxygen and nutrients, leading to damage. Symptoms often include chest pain, shortness of breath, and discomfort in other areas of the upper body. The progression of the disease can lead to complications if not addressed promptly.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507296-21-00Protocol codeAPHP 180610Estimated enrolment700 patientsSponsorAssistance Publique Hopitaux De Paris

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