Oral and Intravenous Methadone for Analgesia in Cardiac Surgery

Comparison of Oral and Intravenous Methadone for Analgesia in Cardiac Surgery

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery; Anesthesia
• Intervention / Treatment: Drug: Oral methadone, immediately prior to transport; Drug: Intravenous methadone

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral methadone, immediately prior to transport	Drug: Oral methadone, immediately prior to transport; Patients will receive 0.4mg/kg PO methadone immediately prior to transport to the operating room
Active Comparator: Intravenous methadone	Drug: Intravenous methadone; Patients will receive 0.3mg/kg IV methadone after induction of general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Pain will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable.	From hospital admission for surgery to 6 hours after extubation postoperatively
Pain score 12 hours after extubation	Pain will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable.	From hospital admission for surgery to 12 hours after extubation postoperatively
Pain score 24 hours after extubation	Pain will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable.	From hospital admission for surgery to 24 hours after extubation postoperatively
Pain score 48 hours after extubation	Pain will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable.	From hospital admission for surgery to 48 hours after extubation postoperatively
Pain score 72 hours after extubation	Pain will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable.	From hospital admission for surgery to 72 hours after extubation postoperatively
Time to extubation	This outcome will monitor the time in minutes from when a patient arrives in the ICU to the time the breathing tube is removed (extubation).	From the time the patient arrives in the ICU intubated until the time the patient is successfully extubated. If the patient is extubated in the operating room, this time will be 0.
Opioid Use in MMEs Prior to Extubation	This outcome will assess the need for pain medications (opioids) to make patients comfortable prior to removing the breathing tube (extubation).	From the time the patient arrives in the ICU intubated until the time the patient is successfully extubated. If the patient is extubated in the operating room, this time will be 0.

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Krishnan Ramanujan, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2025
• Primary Completion (Actual): July 7, 2025
• Study Completion (Actual): July 14, 2025

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: December 5, 2024
• First Posted (Actual): December 6, 2024

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Ketones; Methadone
• Other Study ID Numbers: 24-006579

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No