Authors
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Assistance Publique Hopitaux De Paris -More
Category
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Primary study
Registry of Trials»Clinical Trials Information System
Year
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2026
INTERVENTION: Product Name: PENTHRO X99,9%, liquide pour inhalation par vapeur de 3 mL, Product Code:PRD8812486, Pharmaceutical Form: INHALATION VAPOUR, LIQUID, Other descriptive name: , Strength: , Product Name: , Product Code:SCP1000773, Pharmaceutical Form: , Other descriptive name: , Strength: CONDITION: Acute Myocardial Infarction Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective: 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. Primary end point(s): Proportion of patients achieving pain relief, i.e. pain intensity score on visual analogic scale (VAS) = 3 at 30 minutes. Secondary Objective: To compare the impact of the treatments on cardiovascular system, To compare tolerance of the treatments, particularly respiratory depression and sedation SECONDARY OUTCOME: Secondary end point(s):Impact of the treatments on cardiovascular system: heart rate, arterial blood pressure, pulse oximetry and ECG changes at hospital arrival Secondary end point(s):Pain relief: time before achieving pain relief, i.e. time between randomization and pain intensity score on VAS = 3; Secondary end point(s):Pain relief: time to reach initial pain divided by two (initial VAS / 2) Secondary end point(s):Tolerance of the treatments: : dizziness, pruritus, nausea, vomiting, headache Secondary end point(s):Tolerance of the treatments: respiratory depression: respiratory rate < 10 cycles per minutes Secondary end point(s):Tolerance of the treatments: sedation: Richmond Agitation ‐ Sedation Scale (RASS) = 2 or = ‐2 INCLUSION CRITERIA: 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)., Patient managed in pre‐hospital setting for a ST elevation myocardial infarction (STEMI): STEMI on ECG according to 2017 ESC guidelines
Epistemonikos ID: d0af7001478eafe96af54decb69497666133408c
First added on: Apr 24, 2026