eurotoxic 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.

Phase 4

Completed

• Conditions: neurotoxic adverse effects; unwanted effects on the nervous system; 10062915; 10012221; 10038430

• Registration Number: NL-OMON44278
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Trial ended prematurely

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-02-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 3

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the difference in occurrence of delirium at any<br /><br>time between start of CSCI of morphine or oxycodone and death.<br /><br><br /><br>The Delirium Observation Screening (DOS)-scale is used for screening for<br /><br>presence for delirium. The clinical diagnosis of delirium is confirmed or<br /><br>rejected in accordance with the DSM-IV-TR criteria.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary parameter is the difference in occurrence of<br /><br>allodynia/hyperalgesia at any time between start of CSCI of morphine or<br /><br>oxycodone and death.<br /><br><br /><br>Brushing with a piece of cotton wool on the skin and pin-prick testing is<br /><br>performed to assess for presence of allodynia/hyperalgesia. Items of the<br /><br>Rotterdam Elderly Pain Observation Scale (REPOS) are used to determine presence<br /><br>of pain in subjects who are verbally inadequate responsive.</p><br>