Paracetamol in Addition to WHO Step III Opioids in Chronic Cancer Pain Control

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Blinded withdrawal of regular co-medication with paracetamol in chronic pain patients under strong opioids on pain control.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborator: Swiss National Science Foundation
• Treatments: Acetaminophen

Criteria

Inclusion Criteria:

• Male and female cancer patients receiving a WHO step III opioid (i.e. morphine, oxycodone, methadone, fentanyl, hydromorphone, or buprenorphine) in combination with paracetamol (minimum dose 3 g/day)

• Age ≥ 18 at screening

• Ability to understand the study procedures and to provide written informed consent

• Stable analgesia before randomisation, defined as no required changes in the analgesic treatment during the previous 7 days

Exclusion Criteria:

• Participation in another interventional trial within 30 days prior to randomisation, with the exception of cancer treatment trials

• Changes of the dosage or start of other (co-)analgesics (e.g. tricyclic antidepressants, neuroleptics, nonsteroidal anti-inflammatory drugs (NSAIDs), dipyrone), within the last 7 days preceding randomisation

• Surgery within the 14 days preceding randomisation or surgery planned within the following 14 days after randomisation

• Any circumstances, comorbidities or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the study protocol