RecruitingPhase 4NCT05088876

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

Paracetamol in Addition to WHO Step III Opioids in Chronic Cancer Pain Control - a Randomized, Double-blind, Placebo-controlled, Non-inferiority Study

Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

140 participants

Start Date

Aug 28, 2024

Study Type

INTERVENTIONAL

Conditions

Pain

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria4

Male and female patients receiving a WHO step III opioid (i.e. morphine, oxycodone, methadone, fentanyl, hydromorphone, or buprenorphine) in combination with paracetamol (minimum dose 1.5 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 Criteria4

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 duration of the study
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

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