BMJ supportive & palliative care · 2026
PaSo paracetamol with strong opioids trial: paracetamol versus placebo in conjunction with strong opioids for cancer pain-a pilot randomised placebo-controlled withdrawal trial.
СтатьяНазвание и аннотация: Перевод в очереди
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Hagen Katarina Margareta Rønning, McWilliams Kerry, Bowden Joanna, Harvie Karen, Paulsen Ørnulf, Fallon Marie
Аннотация
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.
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.