Comparing pain relief from methoxyflurane and morphine in heart attack patients
ANalgesic Efficacy and Safety of MOrphiNe Versus Methoxyflurane in Patients With Acute Myocardial Infarction
This study is testing whether inhaled methoxyflurane can provide better pain relief than intravenous morphine for heart attack patients while avoiding some of morphine's side effects.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Collegium Medicum w Bydgoszczy Academic / other |
| Locations | 1 site (Bydgoszcz, Kujawsko-Pomorskie) |
| Trial ID | NCT04476173 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of inhaled methoxyflurane compared to intravenous morphine for pain relief in patients experiencing acute myocardial infarction, specifically ST-elevation myocardial infarction (STEMI) and non-ST-elevation acute coronary syndrome (NSTE-ACS). The research aims to address the adverse effects of morphine, such as gastrointestinal issues, which can hinder the absorption of critical medications. By using methoxyflurane, which does not affect opioid receptors, the study seeks to provide effective pain management without compromising the efficacy of antiplatelet therapies. The trial is designed as a Phase 3 interventional study to gather robust data on these two analgesics.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 diagnosed with STEMI or NSTE-ACS.
Not a fit: Patients with pregnancy, severe heart failure, or uncontrolled hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective pain management option for heart attack patients.
How similar studies have performed: Previous studies have indicated that methoxyflurane is effective for acute pain management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Bydgoszcz, Kujawsko-Pomorskie
- Department of Cardiology — Bydgoszcz, Kujawsko-Pomorskie, Poland (Recruiting)
Study contacts
- Principal investigator: Jacek Kubica, Professor — Collegium Medicum w Bydgoszczy
- Study coordinator: Agata Kosobucka, PhD
- Email: akosobucka@wp.pl
- Phone: +48 525854023
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.