What question did this study set out to answer?

This study aims to validate the efficacy of intravenous patient-controlled analgesia compared to oral opioids for managing severe cancer pain.

May 15, 2026Journal of the National Comprehensive Cancer Network0 citationsOpen Access

Intravenous Patient-Controlled Analgesia Versus Oral Opioids to Maintain Analgesia for Severe Cancer Pain: A Randomized Phase III Trial

RLRongbo LinFujian Medical University LHLang HeChengdu Fifth People's Hospital MLMingqian LuYichang Central People's Hospital

Key Points

This study aims to validate the efficacy of intravenous patient-controlled analgesia compared to oral opioids for managing severe cancer pain.
Randomized phase III trial with 1,349 patients from 48 oncology centers
Patients received bolus-only IPCA-HM, continuous infusion IPCA-HM, or oral morphine for 6 days
Primary outcome measured was average NRS score over days 1-3.
Mean NRS scores for bolus, infusion, and oral arms were 2.36, 2.26, and 2.94, respectively (P<.001)
Bolus regimen was noninferior to infusion with a mean difference of 0.10 (95% CI, -0.01 to 0.20)
Opioid-related adverse events were lower in both IPCA-HM arms (20.1% bolus, 23.0% infusion) compared to oral (33.7%).

Abstract

BACKGROUND: Effective management of severe cancer pain remains challenging. Our phase II study suggested that intravenous patient-controlled analgesia with hydromorphone (IPCA-HM), delivered either as bolus-only or continuous infusion, is superior to oral morphine for patients with severe cancer pain, with bolus-only potentially providing comparable efficacy to infusion while resulting in a lower rate of morphine equivalent dose (MED) escalation. This phase III study aimed to validate these findings. PATIENTS AND METHODS: Patients with solid tumors and severe cancer pain (≥7 at rest on an 11-point Numeric Rating Scale NRS) who achieved successful 24-hour IPCA-HM dose-finding were randomized (2:2:1) to bolus-only IPCA-HM (bolus), continuous infusion IPCA-HM (infusion), or oral morphine (oral) for 6 days. The primary outcome was average NRS score over days 1-3 (3DNRS). RESULTS: Of 1,349 patients from 48 oncology centers, 542 received bolus, 540 infusion, and 267 oral. Mean SD 3DNRS scores were 2.36 0.89, 2.26 0.87, and 2.94 1.16, respectively. Both IPCA-HM arms were statistically significantly better than the oral arm in 3DNRS scores (bolus vs oral: mean difference, 0.58 95% CI, 0.42 to 0.74; infusion vs oral: 0.68 95% CI, 0.52 to 0.84; both P<.001). Bolus was noninferior to infusion (mean difference, 0.10 95% CI, -0.01 to 0.20; predefined noninferiority margin, 0.3; P<.001), achieving noninferiority in opioid-naïve, but not opioid-tolerant, patients. Median (IQR) total MEDs over days 1-6 were 400 (260-692) mg, 643 (380-1,117) mg, and 867 (540-1,313) mg for the bolus, infusion, and oral arms, respectively. Opioid-related adverse events (all grade 1 or 2) were comparable between the bolus (20.1%) and infusion (23.0%) arms, and both were lower than in the oral arm (33.7%). CONCLUSIONS: For severe cancer pain, both IPCA-HM regimens provided statistically significantly better pain relief compared with oral morphine. The bolus regimen achieved noninferior efficacy compared with infusion while requiring lower opioid doses, providing a safe and effective analgesic option.

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