Oral Methadone for Cardiac Surgery

(OMICS Trial)

AC
Overseen ByAnesthesia Clinical Research Unit
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores different methods of using methadone to manage pain after heart surgery. Researchers aim to determine whether taking methadone orally before surgery is more effective than receiving it through an IV during surgery for reducing postoperative pain. Individuals scheduled for elective heart surgery, who do not have chronic pain or other specific health issues, might be suitable candidates for this study. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective methadone can further benefit patients in managing post-surgery pain.

Do I need to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have chronic pain requiring opioid medications or an opioid use disorder, you may not be eligible to participate.

What is the safety track record for methadone?

Research has shown that methadone is generally safe and effective for managing pain during and after heart surgery. Studies found that using methadone during surgery helps control pain without causing major side effects, indicating its safety for this use. Methadone's approval for pain relief in other conditions further supports its safety. Overall, methadone appears to be a safe choice for reducing pain after heart surgery.12345

Why are researchers enthusiastic about this study treatment?

Unlike the standard pain management options for cardiac surgery, which typically involve intravenous opioids like morphine or fentanyl, this study explores methadone delivered both orally and intravenously. Researchers are excited about oral methadone because it offers a unique delivery method that could simplify pain management by potentially reducing the need for complex IV setups before surgery. Additionally, methadone is known for its long-acting pain relief and ability to stabilize opioid receptors, which might provide more sustained control of postoperative pain compared to short-acting alternatives. This could lead to improved patient comfort and potentially faster recovery times.

What evidence suggests that methadone is effective for postoperative pain in cardiac surgery?

Research has shown that methadone can help manage pain after heart surgery. In this trial, participants will receive either oral methadone immediately before transport for surgery or intravenous methadone during surgery. Oral methadone before surgery has shown mixed results; some studies find it doesn't significantly lower pain scores but does reduce the need for other pain medications. In contrast, intravenous methadone during surgery has been linked to better pain control and fewer side effects. Both methods help reduce pain 24 hours after surgery and decrease the need for other opioids upon hospital discharge. Overall, methadone is generally effective and safe for managing pain during recovery from heart surgery.12346

Who Is on the Research Team?

KR

Krishnan Ramanujan, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for patients scheduled for elective cardiac surgery who need pain management. Specific eligibility criteria are not provided, but typically participants must be adults in stable condition and able to take oral medication.

Inclusion Criteria

I am scheduled for planned heart surgery.

Exclusion Criteria

Opioid use disorder on medication assistance treatment
Prolonged QTc >500ms
Intolerance to methadone
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative Treatment

Participants receive oral methadone immediately prior to transport for cardiac surgery

Single administration
1 visit (in-person)

Intraoperative Treatment

Participants receive intravenous methadone during cardiac surgery

During surgery
1 visit (in-person)

Postoperative Monitoring

Participants are monitored for opioid medication use and pain scores post-extubation

72 hours
Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Methadone
Trial Overview The study compares two ways of giving methadone for pain control: one group receives it orally before surgery, while the other gets it intravenously when anesthesia starts. The goal is to see which method better reduces postoperative pain.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Oral methadone, immediately prior to transportExperimental Treatment1 Intervention
Group II: Intravenous methadone intraoperativelyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

Preoperative oral methadone for postoperative pain in ...Results: Twenty-one patients completed the study. Oral methadone did not reduce pain scores in the methadone group (P = 0.08). However, postoperative morphine ...
The role of methadone in cardiac surgery for management ...Intraoperative administration of methadone was associated with better pain control without significant side-effects after cardiac surgery.
NCT07221617 | Oral Methadone in Cardiac SurgeryAn arm type in which a group of participants receives an intervention/treatment considered to be effective (or active) by health care providers.
Intraoperative Methadone in Adult Cardiac Surgical ...Our study results support the safety and efficacy of methadone as an analgesic option in early recovery after cardiac surgery pathways.
The influence of preoperative or intraoperative methadone on ...Preoperative or intraoperative methadone led to reduced pain scores at 24 h postoperatively and reduced opioid requirements at discharge.
Preoperative oral methadone for postoperative pain in ...The primary outcome was pain scores on a 0–10 Verbal Rating Scale. Secondary outcomes included morphine requirements using patient-controlled analgesia (PCA), ...
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