Oral and Intravenous Methadone for Analgesia in Cardiac Surgery

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Cardiac Surgery; Anesthesia

Treatments: Drug: Oral methadone, immediately prior to transport; Drug: Intravenous methadone

Study type: Interventional

Funder types: Other

Identifiers

NCT06720415

24-006579

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Oral methadone, immediately prior to transport

Experimental group

Treatment:

Drug: Oral methadone, immediately prior to transport

Intravenous methadone

Active Comparator group

Treatment:

Drug: Intravenous methadone