Pain
Conditions
Keywords
Pain, Analgesics, Retroperitoneal lymph node dissection
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 effects of the combination of morphine and methadone.
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 pain, it will be a relatively unique example of translating concepts of fundamental aspects of opioid actions seen in the laboratory to the clinical area, and provide a basis for offering new and scientifically- based analgesic regimens. This may provide better pain relief with less opioid related side effects in clinical practice. Purpose: This is a randomized, double blind, parallel arm Phase II study comparing a single dose of 1:1 combination of methadone and morphine with morphine alone in patients with post-operative pain. * The primary objective of this randomized, double blind, parallel arm Phase II 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. * A second goal is to further evaluate any side effects of the combination of morphine and methadone.
Interventions
DRUGMethadone
Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 2 mg
DRUGmethadone and morphine
Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 1 mg and methadone 1 mg
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Time to the third request for the pain medication |
Secondary
| Measure | Time frame |
|---|---|
| To Determine if There Are Any Side Effects From the Combination of Morphine and Methadone When Given Together. | assessed every 10 minutes |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Methadone methadone
Methadone: Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 2 mg | 25 |
| Methadone and Morphine methadone and morphine
methadone and morphine: Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 1 mg and methadone 1 mg | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Not Treated | 7 | 9 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 10 | 7 |
Baseline characteristics
| Characteristic | Methadone | Total | Methadone and Morphine |
|---|---|---|---|
| Age, Continuous | 34.9 years | 33.2 years | 31.6 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 23 Participants | 46 Participants | 23 Participants |
| Region of Enrollment United States | 25 Participants | 50 Participants | 25 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 25 Participants | 50 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 25 | 2 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
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.
Time frame: Time to the third request for the pain medication
Population: Data not collected
Secondary
To Determine if There Are Any Side Effects From the Combination of Morphine and Methadone When Given Together.
Time frame: assessed every 10 minutes
Population: Data not collected