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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523349-86-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Medical Developments International Limited | INDUSTRY |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morphine | Active Comparator | Morphine intra-venous infusion: 3 mg bolus repeated every 5 minutes until obtaining VAS ≤ 3 |
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| Methoxyflurane | Experimental | Patient's self-administration of methoxyflurane (Penthrox®) with dedicated inhaler Initial dose: 3 mL (1 vial). A second 3 mL dose can be used. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | at 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | at 30 minutes |
| Compare the impact of the treatments on arterial blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frederic LAPOSTOLLE, MD,PHD | Contact | 01 48 96 44 54 | +33 | frederic.lapostolle@aphp.fr |
| Frederic ADNET, MD,PHD | Contact | 01 48 96 44 54 | +33 | frederic.adnet@aphp.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Avicenne | Bobigny | 93000 | France |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D002637 | Chest Pain |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008733 | Methoxyflurane |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D005019 | Ethyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
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| Morphine | Drug | Morphine intra-venous infusion: 3 mg bolus repeated every 5 minutes until obtaining VAS ≤ 3. Treatment: from inclusion to hospital arrival |
|
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) |
| at 30 minutes |
| 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) | at 30 minutes |
| Compare the impact of the treatments on ECG | Impact of the treatments on cardiovascular system: ECG changes before discharge from the ambulance | at 30 minutes |
| Compare tolerance of the treatments on respiratory depression | Tolerance of the treatments: respiratory depression: respiratory rate < 10 cycles per minutes (data collected every 5 minutes until to 30 minutes after randomisation and at hospital arrival) | at 30 minutes |
| Compare tolerance of the treatments on sedation | Tolerance of the treatments: sedation: Richmond Agitation Sedation Scale (RASS) ≥ 2 or ≤ -2 (data collected every 5 minutes until to 30 minutes after randomisation and at hospital arrival) | at 30 minutes |
| Compare tolerance of the treatments on dizziness, pruritus, nausea, vomiting, headache | Tolerance of the treatments: dizziness, pruritus, nausea, vomiting, headache (data collected every 5 minutes until to 30 minutes after randomisation and at hospital arrival) | at 30 minutes |
| Compare the impact of the treatments on pain relief | Time before achieving pain relief, i.e. time to reach initial pain divided by two (initial VAS / 2) | From randomization until the first documented pain divided by two, assessed up to 30 minutes |
| Compare the impact of the treatments on pain relief | Time before achieving pain relief, i.e. time between randomisation and pain intensity score on VAS ≤ 3 | From randomization until the first documented pain relief, assessed up to 30 minutes |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D009022 |
| Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |