RecruitingPhase 4NCT06868589

Reducing Pain With Methadone and Ketamine in Liver Transplant

Randomized Clinical Trial of Methadone and Ketamine for Pain Management During Deceased Donor Liver Transplant


Sponsor

Lahey Clinic

Enrollment

50 participants

Start Date

Jun 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if using methadone and ketamine during an adult deceased donor liver transplant can help decrease pain after surgery. The main questions it aims to answer are: * What impact does using methadone and ketamine during a deceased donor liver transplant have on pain after surgery? * Does the use of methadone and ketamine also have an impact on mental confusion (delirium) after surgery? Researchers will compare the use of methadone and ketamine to standard of care to see if the two drugs work to decrease pain and impact delirium after liver transplant. Participants will: * Receive either methadone and ketamine or standard of care during their deceased donor liver transplant. * Allow researchers to follow medical care throughout inpatient stay.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Adult patients ≥ 18 years of age at the time of LT.
  • Undergoing LT from a deceased donor.
  • Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria15

  • Living donor liver transplantation (LDLT).
  • Split liver transplantation (isolated right or left lobe).
  • Acute liver failure (ALF) as the indication for LT.
  • Repeat (redo) liver transplant
  • Simultaneous liver and kidney transplant (SLK)
  • Sedation or high vasopressor use.
  • Subject is intubated and/or mechanically ventilated prior to entering the operating room for LT.
  • Severe Hepatic encephalopathy
  • History of psychiatric disorders such as schizophrenia or bipolar mood disorders
  • History of chronic opioid use, substance abuse or opioid maintenance therapies
  • Any history of allergic reaction to any of the study drugs History of Brugadda, prolonged QT syndrome or QTc in preoperative setting
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
  • Prisoner
  • Pregnant person
  • Operational Exclusion Criterion: Subjects will not be enrolled if study personnel required for protocol execution (e.g., study investigator, research staff or pharmacy staff) are unavailable at the time of transplantation.

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Interventions

DRUGMethadone

Participants in this group will receive one bolus dose of intravenous Methadone and Ketamine at the start of operation

DRUGketamine

Participants in this group will receive one bolus dose of intravenous Methadone and Ketamine at the start of operation

DRUGHydromorphone

Participants in this group will receive standard of care for pain with either intravenous fentanyl and/or hydromorphone boluses during the procedure

DRUGfentanyl

Participants in this group will receive standard of care for pain with either intravenous fentanyl and/or hydromorphone boluses during the procedure


Locations(2)

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

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NCT06868589


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