Oral versus intravenous methadone for pain after elective heart surgery
Oral Methadone In Cardiac Surgery
This study will see if taking methadone by mouth before surgery or receiving it through an IV at anesthesia induction controls pain better after elective heart surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT07221617 on ClinicalTrials.gov |
What this trial studies
Adults undergoing elective cardiac surgery receive methadone either orally before the operation or intravenously at the induction of general anesthesia. Postoperative pain scores, opioid consumption, and recovery measures are collected and compared between the two groups. Key exclusions include chronic outpatient opioid use, opioid use disorder on medication-assisted treatment, prolonged QTc, severe kidney disease, and cirrhosis. The trial is conducted at Mayo Clinic in Rochester, Minnesota.
Who should consider this trial
Good fit: Adults scheduled for elective cardiac surgery who are not using chronic outpatient opioids and who do not have severe renal disease, cirrhosis, prolonged QTc, pregnancy, or methadone intolerance.
Not a fit: Patients on chronic opioid therapy, those receiving medication-assisted treatment for opioid use disorder, people with severe kidney disease or cirrhosis, prolonged QTc, pregnancy, current ICU admission, or methadone intolerance are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, this could identify the best methadone route to improve pain control and reduce additional opioid needs after heart surgery.
How similar studies have performed: Prior work has shown intraoperative methadone can prolong postoperative analgesia and reduce opioid requirements, but direct comparisons of preoperative oral versus IV methadone timing in cardiac surgery are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • Undergoing elective cardiac surgery 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 * Admitted inpatient in an intensive care unit (ICU) immediately prior to surgery * Pregnancy at the time of surgery * 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, M.D. — 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.