Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer
Bolus-only versus bolus plus continuous infusion hydromorphone for refractory cancer pain: a prospective, multicenter, randomized noninferiority trial
By Yan Z, Fu Y, Jin Y and 6 others.
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%.