Bolus-only versus bolus plus continuous infusion hydromorphone for refractory cancer pain: a prospective, multicenter, randomized noninferiority trial.
Zhe Yan, Yanbin Fu, Yi Jin et al.
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In 30 seconds
This prospective, multicenter, randomized noninferiority trial compared bolus-only patient-controlled intravenous hydromorphone analgesia with bolus plus continuous infusion in patients with refractory cancer pain. Among 226 randomized patients, pain relief at 72 hours—defined as at least a 50% reduction in resting pain—occurred in 89.4% with bolus-only administration and 94.2% with combined administration. The between-group difference had a 90% confidence interval of -11.2% to 1.1%, crossing the prespecified noninferiority margin; noninferiority of bolus-only treatment was therefore not demonstrated. Adverse-event incidence was comparable.
Key findings
- At 72 hours, pain relief rates were 89.4% with bolus-only PCIA and 94.2% with bolus plus continuous infusion.
- The between-group difference had a 90% CI of -11.2% to 1.1%, crossing the -10% noninferiority margin.
- Resting and breakthrough cancer pain NRS scores decreased from baseline in both groups (all P < 0.05).
- PCIA-related adverse-event incidence was comparable between groups.
Why it matters
The trial directly compares two commonly considered PCIA delivery modes for refractory cancer pain. Both groups experienced pain-score reductions, but the study did not establish that bolus-only administration provides pain relief noninferior to bolus plus continuous infusion. This distinction matters when interpreting bolus-only use as an equivalent alternative; the comparable adverse-event incidence provides additional safety context.
What to keep in mind
Noninferiority of bolus-only PCIA was not established, so the trial does not support concluding that the two modes are equivalent for the primary pain-relief outcome.