Oral and Intravenous Methadone for Analgesia in Cardiac Surgery

NCT06720415 | Completed Phase 4 FDA Drug

• 1 other identifier: 24-006579
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effects of administration of oral methadone preoperatively and intravenous methadone upon induction of general anesthesia on postoperative pain for patients undergoing elective cardiac surgery.

Conditions

Anesthesia; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Opioid Use in Morphine Milligram Equivalents 24 hours after extubation

  From hospital admission for surgery to 24 hours after the patient is extubated postoperatively

Secondary Outcomes (9)

• Opioid Use in Morphine Milligram Equivalents 48 hours after extubation

  From hospital admission for surgery to 48 hours after the patient is extubated postoperatively

• Opioid Use in Morphine Milligram Equivalents 72 hours after extubation

  From hospital admission for surgery to 72 hours after the patient is extubated postoperatively

• Pain score 6 hours after extubation

  From hospital admission for surgery to 6 hours after extubation postoperatively

• Pain score 12 hours after extubation

  From hospital admission for surgery to 12 hours after extubation postoperatively

• Pain score 24 hours after extubation

  From hospital admission for surgery to 24 hours after extubation postoperatively

Study Arms (2)

Oral methadone, immediately prior to transport

EXPERIMENTAL

Drug: Oral methadone, immediately prior to transport

Intravenous methadone

ACTIVE COMPARATOR

Drug: Intravenous methadone

Interventions

Oral methadone, immediately prior to transport DRUG

Patients will receive 0.4mg/kg PO methadone immediately prior to transport to the operating room

Oral methadone, immediately prior to transport

Intravenous methadone DRUG

Patients will receive 0.3mg/kg IV methadone after induction of general anesthesia

Intravenous methadone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing elective cardiac surgery as the first case of the day in an operating room

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Methadone

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Officials

• Krishnan Ramanujan

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: December 6, 2024
• Study Start: April 14, 2025
• Primary Completion: July 7, 2025
• Study Completion: July 14, 2025
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)