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Clinical trial

ANalgesic Efficacy and Safety of MOrphiNe Versus Methoxyflurane in Patients With Acute Myocardial Infarction

ID
Name
ANEMON-SIRIO3
Description
The purpose of this study is to evaluate analgesic efficacy of inhaled methoxyflurane vs intravenous morphine in patients presenting with acute ST-elevation (STEMI) / non ST-elevation acute coronary syndrome (NSTE-ACS)
Trial arms
Trial start
2020-06-01
Estimated PCD
2024-06-30
Trial end
2024-12-30
Status
Recruiting
Phase
Early phase I
Treatment
Methoxyflurane - Penthrox
ACS patients who received inhaled methoxyflurane as analgesic treatment
Arms:
Methoxyflurane
Morphine
ACS patients who received intravenous morphine as analgesic treatment
Arms:
Morphine
Size
200
Primary endpoint
Measure of pain intensity according to the Numeric Pain Rating Scale (NPRS) 2-3 minutes after drug administration in relation to pain intensity assessed before drug administration
2-3 mins
Measure of pain intensity according to the Numeric Pain Rating Scale (NPRS) immediately after PCI in relation to pain intensity assessed before drug administration
immediately after PCI
Eligibility criteria
Inclusion Criteria: * diagnosis of ST-elevation myocardial infarction (STEMI) or non-ST-elevation acute coronary syndrome (NSTE-ACS) * patients aged from 18 to 80 years Exclusion Criteria: * pregnancy * manifest infection or inflammatory state * cardiogenic shock during screening for eligibility * respiratory failure * heart failure (NYHA class III or IV during screening for eligibility) * uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>100 mmHg)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2023-09-11

1 organization

2 products

2 indications

Organization
Collegium Medicum w Bydgoszczy
Product
Methoxyflurane
Indication
ST Elevation Myocardial Infarction
Indication
Non-ST Segment Elevation Acute Coronary Syndrome
Product
Morphine