Neurotoxic Adverse Effects of Morphine and Oxycodone for Pain in Terminal Patients With Diminished Renal Function
Status:
Terminated
Trial end date:
2018-12-19
Target enrollment:
Participant gender:
Summary
Significant pain is a common condition in dying patients. Continuous subcutaneous infusion
(CSCI) of opioids is the cornerstone in treatment of pain in this last phase of life.
Although morphine is the most frequent used opioid in this respect, burdensome adverse
effects, like delirium and allodynia/hyperalgesia, can occur in dying patients, due to
accumulation of morphine metabolites in decreasing renal function. Oxycodone seems preferable
in this situation, as central effects of circulating metabolites of oxycodone are negligible.
However, studies of sufficient quality investigating the clinical effect of this hypothesis
are lacking at the moment.
This study investigates whether there is a difference in occurrence of delirium and
allodynia/hyperalgesia between oxycodone and morphine. Residents of hospices and somatic or
psychogeriatric (PG) wards of nursing homes in the Netherlands, who are eligible for start of
CSCI of an opioid for the treatment of pain in the terminal phase of life, are randomly
assigned to one of two groups. One group receives CSCI of oxycodone and the other group CSCI
of morphine. 117 patients per group are needed. Occurrence of delirium and
allodynia/hyperalgesia is assessed three times a week until death of the participant. Quality
of dying, as perceived by the patient's relatives, is assessed in an interview with a
relative after death.
Phase:
Phase 4
Details
Lead Sponsor:
Maastricht University Medical Center
Collaborators:
Envida, Maastricht, The Netherlands ZonMw: The Netherlands Organisation for Health Research and Development