Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2026
Bolus-only versus bolus plus continuous infusion hydromorphone for refractory cancer pain: a prospective, multicenter, randomized noninferiority trial.
Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
introductionRefractory cancer pain (RCP) remains difficult to manage despite guideline-based therapy. Patient-controlled intravenous analgesia (PCIA) is increasingly used, yet the optimal administration mode remains unclear.
methodsIn this prospective, multicenter, randomized, non-inferiority trial, patients with refractory cancer pain were enrolled between December 1, 2018, and August 31, 2022, and randomly assigned to either a bolus-only PCIA group (Group B) or a bolus plus continuous infusion group (Group BC). Pain intensity was assessed using the Numerical Rating Scale (NRS). The primary endpoint was the pain relief rate at 72 h after PCIA initiation, defined as the proportion of patients achieving a ≥ 50% reduction in resting pain intensity from baseline. Non-inferiority was evaluated using the 90% confidence interval (CI) for the between-group difference, with a predefined non-inferiority margin of - 10%.
resultsA total of 226 patients were randomized. with 104 assigned to Group B and 111 to Group BC. Both groups showed significant reductions in resting NRS scores and breakthrough cancer pain (BTcP) NRS scores from T1 to T6 compared with baseline (all P < 0.05). At 72 h, the pain relief rate was 89.4% in Group B and 94.2% in Group BC. The between-group difference yielded a 90% CI of - 11.2% to 1.1%, which crossed the predefined non-inferiority margin. Therefore, non-inferiority of Group B compared with Group BC was not demonstrated. The incidence of PCIA-related adverse events was comparable between the two groups.
conclusionNon-inferiority of bolus-only PCIA compared with bolus plus continuous infusion was not established. Nevertheless, both PCIA administration modes provided effective analgesia and demonstrated favorable safety profiles in patients with refractory cancer pain. CLINICAL
trial registrationChinese Clinical Trial Registry, ChiCTR1800020014. Registered 19 November 2018, https://www.chictr.org.cn/showprojEN.html?proj=32731.
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