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Peer-reviewedCC BY-NC 4.0BMJ Supportive & Palliative Care

PaSo paracetamol with strong opioids trial: paracetamol versus placebo in conjunction with strong opioids for cancer pain—a pilot randomised placebo-controlled withdrawal trial

  • Katarina Margareta Rønning Hagen1,2
  • Kerry McWilliams3
  • Joanna Bowden4
  • Karen Harvie3
  • Ørnulf Paulsen1,5
  • Marie Fallon6
6 affiliations
  1. 1University of Oslo, Institute for Clinical Medicine, Oslo, Norway
  2. 2Oncology, Oslo University Hospital, Oslo, Norway
  3. 3Specialist Palliative Care Services, NHS Lanarkshire, Lanarkshire, UK
  4. 4Specialist Palliative Medicine, NHS Fife, Kirkcaldy, UK
  5. 5Palliative Care Unit, Telemark Hospital, Skien, Norway
  6. 6Palliative Medicine, University of Edinburgh Western General Hospital, Edinburgh, UK
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Abstract

Objectives: Clinical guidelines, including the WHO analgesic ladder, advocate paracetamol in conjunction with strong opioids for moderate to severe cancer pain despite a lack of evidence for its efficacy in this setting.

This pilot study aimed to evaluate the feasibility of a larger randomised controlled trial (RCT) with the aim of establishing whether paracetamol combined with strong opioids provides superior analgesia for cancer-related pain over strong opioids alone.

Methods: Adult patients with incurable cancer taking regular paracetamol and strong opioids with an average pain score 2–8 on a Numeric Rating Scale (NRS 0–10) in the past 24 hours were randomised to receive either paracetamol or placebo for 13 days, with assessments at day 7 and 14. Outcomes were recruitment, retention, appropriateness of study design, patient acceptability and early signals of pain outcome.

Results: Thirty-four participants were recruited and 28 randomised at 12 months. After 7 months, the intervention phase was reduced to 7 days to improve recruitment and mitigate attrition. Retention was high but the clinical team assessed 7 days in the study as adequate and less burdensome for the patients. Average pain (NRS) on day 7 (change from baseline) was similar in the placebo group (−0.27) versus the paracetamol group (−0.46). Groups difference: −0.19, 95% CI −1.1 to 0.7, (p=0.67). Patient recruitment was slow. Due to this, the study did not progress to a definitive RCT.

Conclusion: This pilot study demonstrates feasibility of the withdrawal design but signalled the need for a different recruitment strategy and a shorter study. Notably, there were no adverse pain outcomes, as NRS scores and opioid requirements didn’t increase.

Trial registration number: NCT02706769.

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Cite

BibTeXRIS
BibTeX
@article{hagen2026paso,
  title = {{PaSo paracetamol with strong opioids trial: paracetamol versus placebo in conjunction with strong opioids for cancer pain—a pilot randomised placebo-controlled withdrawal trial}},
  author = {Katarina Margareta Rønning Hagen and Kerry McWilliams and Joanna Bowden and Karen Harvie and Ørnulf Paulsen and Marie Fallon},
  journal = {BMJ Supportive \& Palliative Care},
  year = {2026},
  month = jun,
  doi = {10.1136/spcare-2026-006267},
  url = {https://doi.org/10.1136/spcare-2026-006267},
  note = {CC BY-NC 4.0},
}
RIS
TY  - JOUR
TI  - PaSo paracetamol with strong opioids trial: paracetamol versus placebo in conjunction with strong opioids for cancer pain—a pilot randomised placebo-controlled withdrawal trial
AU  - Katarina Margareta Rønning Hagen
AU  - Kerry McWilliams
AU  - Joanna Bowden
AU  - Karen Harvie
AU  - Ørnulf Paulsen
AU  - Marie Fallon
PY  - 2026
DA  - 2026/06/17
JO  - BMJ Supportive & Palliative Care
DO  - 10.1136/spcare-2026-006267
UR  - https://doi.org/10.1136/spcare-2026-006267
AB  - Objectives: Clinical guidelines, including the WHO analgesic ladder, advocate paracetamol in conjunction with strong opioids for moderate to severe cancer pain despite a lack of evidence for its efficacy in this setting.  This pilot study aimed to evaluate the feasibility of a larger randomised controlled trial (RCT) with the aim of establishing whether paracetamol combined with strong opioids provides superior analgesia for cancer-related pain over strong opioids alone.  Methods: Adult patients with incurable cancer taking regular paracetamol and strong opioids with an average pain score 2–8 on a Numeric Rating Scale (NRS 0–10) in the past 24 hours were randomised to receive either paracetamol or placebo for 13 days, with assessments at day 7 and 14. Outcomes were recruitment, retention, appropriateness of study design, patient acceptability and early signals of pain outcome.  Results: Thirty-four participants were recruited and 28 randomised at 12 months. After 7 months, the intervention phase was reduced to 7 days to improve recruitment and mitigate attrition. Retention was high but the clinical team assessed 7 days in the study as adequate and less burdensome for the patients. Average pain (NRS) on day 7 (change from baseline) was similar in the placebo group (−0.27) versus the paracetamol group (−0.46). Groups difference: −0.19, 95% CI −1.1 to 0.7, (p=0.67). Patient recruitment was slow. Due to this, the study did not progress to a definitive RCT.  Conclusion: This pilot study demonstrates feasibility of the withdrawal design but signalled the need for a different recruitment strategy and a shorter study. Notably, there were no adverse pain outcomes, as NRS scores and opioid requirements didn’t increase.  Trial registration number: NCT02706769.
SN  - 2045-435X
SN  - 2045-4368
ER  -