Adverse effects of morphine and oxycodone for treatment of pain in dying patients.

Phase 1

• Conditions: - The subject is in the terminal phase, i.e. death in the near future is expected by the treating physician; - The subject has a diminished renal function, defined as an eGFR < 50 ml/min/1.73m2; - Start of treatment of pain with continuous subcutaneous infusion of an opioid is indicated by the treating physician.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2017-002192-25-NL
• Lead Sponsor: Center of Expertise in Palliative Care, Maastricht University Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-26
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 234

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 234
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 234

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified