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Comparison of A Single Dose Combination of Methadone and Morphine With Morphine Alone for Treating Post-operative Pain

Memorial Sloan Kettering Cancer Center (MSK) logo

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Completed
Phase 2

Conditions

Pain

Treatments

Drug: methadone and morphine
Drug: Methadone

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups

1
Active Comparator group
Description:
methadone
Treatment:
Drug: Methadone
2
Experimental group
Description:
methadone and morphine
Treatment:
Drug: methadone and morphine

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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