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Completed

NCT Number: NCT06720415

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.

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Key information

Conditions

Anesthesia Cardiac Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral methadone, immediately prior to transport

Drug

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

Intravenous methadone

Drug

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

Primary outcomes

  1. Opioid Use in Morphine Milligram Equivalents 24 hours after extubation

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

Secondary outcomes

  1. Opioid Use in Morphine Milligram Equivalents 48 hours after extubation

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

  2. Opioid Use in Morphine Milligram Equivalents 72 hours after extubation

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

  3. Pain score 6 hours after extubation

    Time frame: 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.

  4. Pain score 12 hours after extubation

    Time frame: 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.

  5. Pain score 24 hours after extubation

    Time frame: 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.

  6. Pain score 48 hours after extubation

    Time frame: 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.

  7. Pain score 72 hours after extubation

    Time frame: 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.

  8. Time to extubation

    Time frame: 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).

  9. Opioid Use in MMEs Prior to Extubation

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Comparison of Oral and Intravenous Methadone for Analgesia in Cardiac Surgery

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 6, 2024
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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