Clinical trial · Interventional
Paracetamol Versus Placebo in Conjunction With Strong Opioids for Cancer Pain
A Double-blind Randomised Parallel Group Trial of Paracetamol Versus Placebo in Conjunction With Strong Opioids for Cancer Related Pain
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding was terminated early due to slow recruitment.
Summary
Brief summary (as posted)
National guidelines advocate the use of paracetamol in conjunction with strong opioids for cancer pain, despite a lack of evidence for its efficacy. Work is needed to examine the analgesic benefit of paracetamol in this large patient group. The investigators aim to establish if paracetamol in combination with strong opioids provides superior analgesia for cancer related pain over strong opioids alone.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paracetamol | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Paracetamol
- description
- Participants will take blinded Paracetamol (as they were taking before entering the study)
- interventionNames
- Drug: Paracetamol
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Participants will take blinded Paracetamol
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Proportion of participants with a 30% increase in total Brief Pain Inventory between day 0 and day 14 in the active drug group versus the placebo group.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 16 years and over 2. Under palliative care/oncology service review 3. Diagnosis of incurable cancer 4. Clinician-predicted life expectancy \>2 months 5. Anticipated to be clinically stable for duration of study involvement 6. Receiving daily regular strong opioids 7. Able to take study drug/placebo in its current form 8. Prescribed and taking paracetamol 1g four times a day 9. Average pain \>3 and \<9 in past 24 hours 10. Able to provide written informed consent 11. Able to complete necessary assessments required as part of the trial 12. Average NRS pain score stable (ie. maximum range of 1 point) for the three consecutive days prior to randomisation Exclusion Criteria: 1. Pain which the clinician deems to be unstable 2. Clinically significant renal or liver disease 3. Weight less than 50kg 4. Those whose pain is expected to change during the course of the study as a result of oncological or other treatments 5. Co-enrolment in other drug trials 6. Known to be pregnant or breast-feeding at the time of recruitment 7. Previously enrolled in this study
References
Publications (1)
- DERIVEDHagen KMR, McWilliams K, Bowden J, Harvie K, Paulsen O, Fallon M. PaSo paracetamol with strong opioids trial: paracetamol versus placebo in conjunction with strong opioids for cancer pain-a pilot randomised placebo-controlled withdrawal trial. BMJ Support Palliat Care. 2026 Jun 17:spcare-2026-006267. doi: 10.1136/spcare-2026-006267. Online ahead of print. PMID 42309698