N/A N=60 Randomized Double-blind Treatment

Methadone in Ambulatory Surgery

Post-operative Pain · Anesthesia

Bottom Line

View on ClinicalTrials.gov: NCT02300077 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2019

Primary outcome: Primary: Intraoperative Opioid Administration — 25; 5.6; 8.6 morphine equivalents mg — p=0.0001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: methadone (Drug); Control (Intra-operative administration of opioids, other than methadone) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Washington University School of Medicine
Primary completion: Feb 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Intraoperative Opioid Administration	25; 5.6; 8.6	0.0001 sig
PRIMARY Postoperative Opioid Administration	10; 5.4; 3.3	0.01 sig
SECONDARY Opioid Consumption Within First 30 Postoperative Days	10; 7; 5	0.001 sig
SECONDARY Pain Relief Within First 30 Postoperative Days	1; 1; 0	0.02 sig

Summary

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.

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT02300077). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.