Comparing oral and intravenous methadone for pain relief in heart surgery
Comparison of Oral and Intravenous Methadone for Analgesia in Cardiac Surgery
This study tests whether taking methadone by mouth before heart surgery works better for pain relief after the surgery compared to getting it through an IV during anesthesia.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06720415 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of oral methadone administered before surgery compared to intravenous methadone given during the induction of general anesthesia in patients undergoing elective cardiac surgery. The goal is to determine which method provides better postoperative pain management. Participants will receive either form of methadone to assess their pain levels after the procedure. This is a Phase 4 interventional study conducted at the Mayo Clinic.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for elective cardiac surgery as the first case of the day.
Not a fit: Patients with chronic pain requiring opioid medications, opioid use disorder, or significant comorbidities such as severe kidney disease or cirrhosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing cardiac surgery.
How similar studies have performed: Other studies have explored methadone for pain management, but this specific comparison of oral versus intravenous administration in cardiac surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • Undergoing elective cardiac surgery as the first case of the day in an operating room Exclusion Criteria: * Chronic pain requiring opioid medications as an outpatient * Opioid use disorder on medication assistance treatment * Prolonged QTc \> 500ms * Chronic kidney disease with eGFR \< 30mL/min * Documented cirrhosis * Intolerance to methadone * Subsequent surgeries after index surgery
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Krishnan Ramanujan — Mayo Clinic
- Study coordinator: Anesthesia Clinical Research Unit
- Email: Paul.Johar@mayo.edu
- Phone: 866-265-9263
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.