Methadone in Ambulatory Surgery

The Washington University

Status: Completed

Conditions: Post-operative Pain; Anesthesia

Treatments: Drug: methadone; Drug: Control (Intra-operative administration of opioids, other than methadone)

Study type: Interventional

Funder types: Other

Identifiers

NCT02300077

201408002

Details and patient eligibility

About

The μ-opioid receptor agonist methadone is frequently used in adult anesthesia and adult pain therapy. Methadone has an extremely long half-life, which confers therapeutic advantage by providing more stable plasma concentrations and long-lasting pain relief. Methadone perioperative pharmacokinetics and effectiveness in perioperative pain relief in inpatients is well characterized. There is, however, no information on methadone use in an ambulatory surgery setting and outpatient procedures. This pilot investigation will determine effectiveness of intraoperative methadone in reducing postoperative opioid consumption and providing improved pain relief in patients undergoing moderately painful, ambulatory surgical procedures.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-65 years
• Undergoing general anesthesia and moderately painful, ambulatory surgical procedures with anticipated overnight, postop hospital stay of < 24 hours
• Signed, written, informed consent

Exclusion criteria

• History of or known liver or kidney disease.
• Females who are pregnant or nursing.
• Opioid tolerant patients (e.g. preoperative methadone therapy or use of fentanyl transdermal patches)
• History of allergy to methadone

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Control

Active Comparator group

Description:

Control (Intra-operative administration of opioids, other than methadone)

Treatment:

Drug: Control (Intra-operative administration of opioids, other than methadone)

Treatment methadone 0.1 mg/kg

Active Comparator group

Description:

methadone 0.1 mg/kg

Treatment:

Drug: methadone

Treatment methadone 0.15 mg/kg

Active Comparator group

Treatment:

Drug: methadone