A Case Series Investigating the efficacy of Rotation to Methadone in Palliative Patients with Cancer Related Pain
A Case Series Investigating change in self-rated pain following Rotation to Methadone in Palliative Patients with Cancer Related Pain
Brisbane South Palliative Care Collaborative
20 participants
Dec 17, 2009
Interventional
Conditions
Summary
This project has been designed to investigate the efficacy of rotation to methadone for pain control in people with cancer whose pain is uncontrolled despite substantial increases in the dose of their prescribed narcotic. By uncontrolled we mean that the person has rated their pain as being equal to or above 4 on an 11 point pain rating scale that ranges from 0 (equivalent to no pain at all), to 10 (equivalent to unbearable pain). To be eligible for this study, a person’s pain must have been clinically assessed to have two different components. One component relates to the type of pain that results when injured body tissues cause pain receptors to fire (known as nociceptive pain) and the other component relates to the type of pain that results when nervous tissues is damaged (known as neuropathic pain). People who meet these conditions will be rotated to a dose of methadone that is equivalent to their previous narcotic does in terms of analgesic potential. They will be required to maintain a daily diary about their pain levels, possible narcotic side effects (such as constipation), quality of life and mood. Diary entries before rotation to methadone will be compared statistically to diary entries after rotation to methadone. If people are improved with rotation to methadone then they can keep taking it.
Eligibility
Inclusion Criteria6
- 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 Criteria7
- 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
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Interventions
There are 3 phases to this case series intervention. During Phase 1 all patients will have their baseline narcotic increased by at least 30% with actual dose being determined by the treating physician. After 3-5 days if pain levels persist above 4 on a Numeric Rating Scale (NRS) with values ranging from 0 (none) to 10 (unbearable) or the patient reports unacceptable narcotic side-effects and the patient is in agreement they will be admitted to a specialist palliative care unit (if not already an inpatient). Phase 2 involves the patient having their current narcotic ceased and an equianalgesic dose of methadone(physeptone) commenced. Patients will be ordered appropriate breakthrough medications during this time. Patients will be monitored for emergent signs of central nervous system toxicity including respiratory depression while doses of methadone are titrated until the patient is stabilized with pain scores less than 4 on the NRS. Phase 3 involves the patient being discharged home and monitored for a further 4 days. If people are improved with rotation to methadone then they can keep taking it. Throughout the study period patients will be asked to keep a daily diary. The primary outcome variable is change in rated pain from pre to post methadone rotation. The secondary outcome variables include subjective ratings of nausea and vomiting, cognitive impairment (drowsiness and unclear thinking), constipation, mood and quality of life. These changes will be assessed in the same way as subjective pain. Duration is approximately 2 to 3 weeks
Locations(1)
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ACTRN12609001071213