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. - MOSART-study

Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 3 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

Trial ended prematurely

•- 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.

•- 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.

发起方

Medisch Universitair Ziekenhuis Maastricht