Pain Clinical Trial
— MOSARTOfficial title:
Neurotoxic Adverse Effects of Morphine and Oxycodone in Continuous Subcutaneous Infusion for Treatment of Pain in Terminal Patients With Diminished Renal Function: a Randomized Controlled Trial
Verified date | March 2019 |
Source | Maastricht University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 8 |
Est. completion date | December 19, 2018 |
Est. primary completion date | December 19, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - minimal age of 18 years at the time of inclusion; - the subject is in the terminal phase, i.e. death in the near future is expected by the treating physician; - start of CSCI with an opioid for treatment of pain is indicated by the treating physician; - willingness to allow one-time blood collection for assessment of renal function (eGFR); - a signed informed consent is given by the participant or his/her legal representative. Exclusion Criteria: - delirium at the time of inclusion; - opioid induced hyperalgesia (OIH) at the time of inclusion; - a medical necessity to apply a different opioid than morphine or oxycodone, such as previously demonstrated non-response to morphine or oxycodone (defined as a complete absence of any pain reduction after appropriate dosage), previously demonstrated unacceptable side effects of morphine or oxycodone, or a medical indication for an opioid with NMDA-receptor-antagonistic properties (currently only known for methadone); - a documented allergy for morphine or oxycodone. Subjects with an eGFR >50 ml/min/1.73m2 should not be included in the study, because accumulation of metabolites is considered to be irrelevant in this range of renal functions. Despite this fact, we cannot formulate an unaffected renal function as an exclusion criterion prior to allocation, because the time needed for assessment of the renal function could lead to either an unethical delay in treatment of pain or occurrence of death even before the lab results are known. Therefore renal function is assessed after inclusion. In case a subject turns out to exceed the threshold of 50 ml/min/1.73m2, this will be considered as meeting an extended exclusion criterion and the subject concerned will be replaced by a new subject. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Envida - De Wilgenhof | Bunde | Limburg |
Netherlands | Envida - De Bron | Eijsden | Limburg |
Netherlands | Envida - Klein Gulpen | Gulpen | Limburg |
Netherlands | Envida - Croonenhoff | Maastricht | Limburg |
Netherlands | Envida - De Mins | Maastricht | Limburg |
Netherlands | Envida - De Zeven Bronnen | Maastricht | Limburg |
Netherlands | Envida - Grubbeveld | Maastricht | Limburg |
Netherlands | Envida - Hagerpoort | Maastricht | Limburg |
Netherlands | Envida - Hospice Trajectum | Maastricht | Limburg |
Netherlands | Envida - Koepelhof | Maastricht | Limburg |
Netherlands | Envida - La Valence | Maastricht | Limburg |
Netherlands | Envida - Larisa | Maastricht | Limburg |
Netherlands | Envida - Appelgaard | Margraten | Limburg |
Netherlands | Envida - De Lommer | Margraten | Limburg |
Netherlands | Envida - Beukeloord | Meerssen | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center | Envida, Maastricht, The Netherlands, ZonMw: The Netherlands Organisation for Health Research and Development |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Time between start of CSCI and death | Time between the start of CSCI with the assigned opioid and death | From date of randomization until date of death, with an estimated average of 1 week. | |
Other | Pain scores | Pain scores (NRS or REPOS) at rest prior to testing for allodynia/hyperalgia | Three times a week, from date of randomization until date of death, with an estimated average of 1 week. | |
Other | Quality of Dying and Death | Structured interview with a relative to assess the perceived quality of dying. | Two weeks after death | |
Primary | Occurrence of delirium | The Delirium Observation Screening (DOS)-scale is scored by the nursing staff on a daily basis to screen for presence of delirium. In case this screening instrument indicates a possible presence of delirium, the clinical diagnosis of delirium will be confirmed or reject by a psychologist in accordance with the DSM-IV-TR criteria. | Daily, from date of randomization until date of death, with an estimated average of 1 week. | |
Secondary | Occurrence of allodynia/hyperalgesia | Presence of allodynia or hyperalgesia is assessed by asking the subject whether respectively lightly brushing with a piece of cotton wool on the skin or performing pin-prick testing provokes pain or aggravates already existing pain. In case the subject is not able to adequately respond verbally the items of the Rotterdam Elderly Pain Observation Scale (REPOS) are used to determine presence of a painful response | Three times a week, from date of randomization until date of death, with an estimated average of 1 week. |
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