Bolus-only versus bolus plus continuous infusion hydromorphone for refractory cancer pain: a prospective, multicenter, randomized noninferiority trial.
8 affiliations
- 1Department of Pain Medicine, College of Medicine, the First Affiliated Hospital, Zhejiang University, Hangzhou, China.
- 2Department of Pain Medicine, Affiliated Hospital of Medical School, Jinling Hospital, Nanjing University, Nanjing, China.
- 3Department of Pain Medicine, Hang Zhou Red Cross Hospital, Hangzhou, China.
- 4Department of Rare Cancer & Head and Neck Medical Oncology, The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Basic Medicine and Cancer (IBMC), Chinese Academy of Sciences, Hangzhou, China.
- 5Department of Pain Medicine, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.
- 6Department of Medical Oncology, The First People's Hospital of Linping District, Hangzhou, Zhejiang Province, China.
- 7Department of Pain Medicine, Weihai Municipal Hospital, Weihai, China.
- 8Department of Pain Medicine, College of Medicine, the First Affiliated Hospital, Zhejiang University, Hangzhou, China. [email protected].
Abstract
Introduction
Refractory 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.Methods
In 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%.Results
A 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.Conclusion
Non-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 registration
Chinese Clinical Trial Registry, ChiCTR1800020014. Registered 19 November 2018, https://www.chictr.org.cn/showprojEN.html?proj=32731.
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BibTeX
@article{yan2026bolusonly,
title = {{Bolus-only versus bolus plus continuous infusion hydromorphone for refractory cancer pain: a prospective, multicenter, randomized noninferiority trial.}},
author = {Zhe Yan and Yanbin Fu and Yi Jin and Wensheng Zhao and Liyan Gong and Guanglun Xie and Li Zhou and Demin Tian and Zhiying Feng},
journal = {Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer},
year = {2026},
month = oct,
doi = {10.1007/s00520-026-11323-4},
url = {https://europepmc.org/article/MED/42911418},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Bolus-only versus bolus plus continuous infusion hydromorphone for refractory cancer pain: a prospective, multicenter, randomized noninferiority trial.
AU - Zhe Yan
AU - Yanbin Fu
AU - Yi Jin
AU - Wensheng Zhao
AU - Liyan Gong
AU - Guanglun Xie
AU - Li Zhou
AU - Demin Tian
AU - Zhiying Feng
PY - 2026
DA - 2026/10/22
JO - Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer
DO - 10.1007/s00520-026-11323-4
UR - https://europepmc.org/article/MED/42911418
AB - Introduction Refractory 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.Methods In 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%.Results A 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.Conclusion Non-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 registration Chinese Clinical Trial Registry, ChiCTR1800020014. Registered 19 November 2018, https://www.chictr.org.cn/showprojEN.html?proj=32731.
SN - 0941-4355
SN - 1433-7339
ER -