Oral and Intravenous Methadone for Analgesia in Cardiac Surgery

Phase 4

Recruiting

• Conditions: Anesthesia; Cardiac Surgery
• Interventions: Drug: Intravenous methadone; Drug: Oral methadone, immediately prior to transport

• Registration Number: NCT06720415
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-12-05
• Study First Posted: 2024-12-06
• Status Verified: 2025-04
• Study Start: 2025-04-14
• Last Update Submitted: 2025-04-20
• Last Update Posted: 2025-04-22
• Primary Completion: 2025-08-30
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous methadone	Intravenous methadone	-
Oral methadone, immediately prior to transport	Oral methadone, immediately prior to transport	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable.
Pain score 12 hours after extubation	From hospital admission for surgery to 12 hours after extubation postoperatively	Pain will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable.
Pain score 24 hours after extubation	From hospital admission for surgery to 24 hours after extubation postoperatively	Pain will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable.
Pain score 48 hours after extubation	From hospital admission for surgery to 48 hours after extubation postoperatively	Pain will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable.
Pain score 72 hours after extubation	From hospital admission for surgery to 72 hours after extubation postoperatively	Pain will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable.
Time to 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.	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).
Opioid Use in MMEs Prior to 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.	This outcome will assess the need for pain medications (opioids) to make patients comfortable prior to removing the breathing tube (extubation).

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States