A Case Series Investigating the efficacy of Rotation to Methadone in Palliative Patients with Cancer Related Pai

Phase 4

• Conditions: Analgesic effectiveness of rotation to methadone for palliative patients experiencing pain with both nociceptive and neuropathic qualities and that has been inadequately controlled by escalating doses of other narcotics; Cancer - Other cancer types; Anaesthesiology - Pain management

• Registration Number: ACTRN12609001071213
• Lead Sponsor: Brisbane South Palliative Care Collaborative

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-12-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

*Patients reporting uncontrolled pain (defined as 4 or greater on a numerical rating scale 0-10 despite the use of regular background narcotics +/- adjuvants
*A component of the patients pain must be neoropathic as assessed using a validated neuropathic pain diagnostic assessment tool, the Douleur Neuropathique en 4 (DN4)
*Able to give informed consent in English
*Willing to be admitted to an inpatient facility for rotation to methadone
*Mini mental state exam (MMSE) score = or above 25/30
*Unsuitable for, or refusing, non-pharmacological interventions e.g. nerve blocks for pain

Exclusion Criteria

*Patients less than 18 years of age
*Patients in whom the use of methadone is contraindicated e.g. using Monoamine oxidase inhibitors (MAOs), active alcoholism
*Patients with known risk factors for a prolonged QT interval
*Patients who have received treatments in the past 2 weeks likely to impact on pain levels e.g. chemotherapy, or who receive such therapy during the study period
*Changes in concomitant analgesic medication during the study period
*Any patient, in the opinion of the researchers, who is unable to comply with the study protocol
*Life expectancy less than 3 weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean difference in pain as rated on an 11 point NRS over the study period and global impression of pain control.[Participants will keep a daily diary commencing the day after the patient is consented and prior to rotation onto Physeptone until 4 days following discharge from the in-patient unit and will record all breakthrough/ rescue medications. To provide a more stable estimate of change in pain, an averaged rating over the last 3 days prior to admission will be compared to that of the last 3 days post-discharge and subsequent exit from the study. <br>Global impression of pain will be assessed on exit from the study]