Methadone Associated With Morphine for Cancer Pain

Analgesic Effect Evaluation of Methadone Associated With Morphine for Cancer Pain: Prospective Randomized Study

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03324815

Enrollment

Registered

2017-10-30

Start date

2017-03-02

Completion date

2018-08-30

Last updated

2017-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Morphine, Methadone, Pain

Brief summary

The study was prospective, randomized. Patients with cancer pain were evaluated, one group receiving methadone with morphine and another group receiving morphine as the only opioid. Pain intensity, total morphine dose and adverse effects were evaluated.

Detailed description

Opioids are the most important analgesics for the relief of cancer pain. In addition tolerance and hyperalgesia may ocurr as a consequence of treatment with these drugs. Medications for pain relief may also cause increased pain. NMDA receptor blockers may prevent or reduce the development of hyperalgesia. Methadone is a weak NMDA receptor antagonist and therefore its association could prevent hyperalgesia. The primary endpoint of the study was whether the administration of low dose methadone associated with morphine promotes better analgesic effect in patients with cancer pain, And secondarily to assess whether there is a reduction in the total dose of opioid needed for pain relief, and whether reduction of the opioid-related adverse effects occurs.

Interventions

DRUGMethadone

Pain Treatment

DRUGMorphine

Pain Treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Approved by the Ethics Committee * signed the informed consent * cancer pain * starting the WHO thirth analgesic ladder,

Exclusion criteria

* cognitive impairment * psychiatric disease * illicit drug user * hypersensitivity to the study drugs * pregnant

Design outcomes

Primary

Measure	Time frame	Description
Opioid consumption	3 months	Total dose of morphine used by the patient

Secondary

Measure	Time frame	Description
Pain intensity	3 months	Measure of pain intensity by verbal numerical rating score (VNRS - zero to 10) where 0 is no pain and 10 is the worst pain imaginable. Values between 0 and 3 mean a good result, between 4 and 6 a poor result and between 7 and 10 a very poor result.

Countries

Brazil

Contacts

Primary ContactFeliciano NC Duarte, MD

feliciano.contardo@gmail.com55 11 99265 7272

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026