Phase 2
Completed N=50
Comparison of A Single Dose Combination of Methadone and Morphine With Morphine Alone for Treating Post-operative Pain
Source: ClinicalTrials.gov NCT00142519 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: The Primary Goal of This Study is to Compare the Analgesic Effects of a Combination of Morphine and Methadone With Morphine Alone to Determine Synergistic Activity of mu Opioid Analgesics in Patients With Post-operative Pain.
Summary
This is a randomized Phase II study testing the effectiveness of the combination of morphine and methadone versus morphine alone in relieving pain. A second goal is to further evaluate any side effects of the combination of morphine and methadone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Goal of This Study is to Compare the Analgesic Effects of a Combination of Morphine and Methadone With Morphine Alone to Determine Synergistic Activity of mu Opioid Analgesics in Patients With Post-operative Pain. |
— | — |
| SECONDARY To Determine if There Are Any Side Effects From the Combination of Morphine and Methadone When Given Together. |
— | — |
Eligibility Criteria
Inclusion Criteria
- Retroperitoneal lymph node dissection
- Planned post-operative analgesia with PCA at 1 mg continuous infusion and 1 mg every 10 minutes
- 18 years of age or older
- English-speaking
- Give informed consent to participate in this study
Exclusion Criteria
- Known hypersensitivity to methadone or morphine
- Patients with past or present history of substance abuse
- Patients with a history of methadone treatment
- Patients with a history of chronic pain requiring daily analgesic use for more than 3 months
- Patients treated with opioids within one month from the scheduled surgery
- Creatinine clearance less than 50 mg/kg (using Cockcroft-Gault Equation).
- Neurologic or psychiatric disease sufficient, in the doctor's opinion, to compromise data collection
Data sourced from ClinicalTrials.gov (NCT00142519). 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.