Status:
COMPLETED
Comparison of A Single Dose Combination of Methadone and Morphine With Morphine Alone for Treating Post-operative Pain
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 effect...
Detailed Description
Rationale: Experimental data demonstrates a profound analgesic synergy between morphine and methadone when co-administered systemically in mice. If this type of synergy can be demonstrated in clinical...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00142519
Start Date
March 1 2005
End Date
July 1 2018
Last Update
March 15 2019
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065