N/A
Completed N=60
Methadone in Ambulatory Surgery
Post-operative Pain · Anesthesia
Source: ClinicalTrials.gov NCT02300077 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Intraoperative Opioid Administration — 25; 5.6; 8.6 morphine equivalents mg — p=0.0001
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.
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 |
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
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. Informational only — not medical advice.