HSK21542 for Postoperative Analgesia in Gynecological Surgery: A Pooled Post-Hoc Analysis of Two Phase III Randomized Controlled Trials.
Shui Yu, Lijing Zou, Siwei Dong et al.
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In 30 seconds
This pooled post-hoc analysis combined two phase III, multicenter, triple-blinded randomized trials of HSK21542 for postoperative pain after elective gynecological surgery. Among 370 patients, inverse-probability-weighted analyses found greater pain-intensity reductions with HSK21542 than placebo over 12 and 24 hours (least-squares mean differences −8.1 and −16.3, respectively; both P < .001). Pain reduction did not differ significantly from tramadol. Compared with placebo, HSK21542 also improved early relief from severe pain and reduced rescue-analgesic use; nausea and vomiting were less frequent than with tramadol.
Key findings
- Compared with placebo, HSK21542 improved SPID at 12 and 24 hours, with least-squares mean differences of −8.1 and −16.3, respectively (both P < .001).
- Severe-pain relief at 0 to 12 hours occurred in 92.7% with HSK21542 versus 82.7% with placebo (P < .001).
- Rescue doses were lower with HSK21542 than placebo at 0 to 12 and 0 to 24 hours: 0.00 [IQR 0.00-1.00] versus 1.00 [IQR 0.00-2.00] in both periods (both P < .001).
- Nausea and vomiting were less frequent with HSK21542 than tramadol (24.7% vs 66.7% and 21.3% vs 60.5%, respectively).
Why it matters
Postoperative pain after gynecological surgery can involve both visceral and somatic components, while analgesics may cause adverse effects. These findings suggest HSK21542 may provide analgesia comparable to tramadol, with fewer reported gastrointestinal adverse events, and better pain outcomes than placebo. The results add evidence about a potential analgesic option, although the pooled post-hoc analysis does not establish comparative effectiveness beyond the studied trials.
What to keep in mind
This was a pooled post-hoc analysis of two trials, rather than a prospectively designed pooled comparison.