HSK21542 for Postoperative Analgesia in Gynecological Surgery: A Pooled Post-Hoc Analysis of Two Phase III Randomized Controlled Trials
Authors' conclusion
HSK21542 could provide adequate postoperative analgesia with few adverse events in patients undergoing gynecological surgery.
Study context
- Population
- Patients undergoing elective gynecological surgeryanalysed
- Participants
- 370 patients
- Comparison
- HSK21542 vs placebo vs tramadol
- HSK21542n = 150
- Placebon = 139reference
- Tramadoln = 81
- Primary endpoint
- Summed pain-intensity difference over 12 and 24 h (SPID 12h and SPID 24h)
- Follow-up
- 12 and 24 hours
Methodological detailsmulticentre, triple-blinded, inverse probability of treatment weighting (IPTW)-adjusted
- Multicentre
- Triple-blinded
- IPTW-adjusted
Primary result
As reported in the abstract
SPID 12h and SPID 24h
Least-squares mean difference
−8.1
P < 0.001
Study 301: HSK21542 · SPID 12h
Least-squares mean difference
−16.3
P < 0.001
Study 303: HSK21542 · SPID 24h
Secondary outcomes
| Outcome | HSK21542 | Placebo | P value |
|---|---|---|---|
| Relief from severe pain · 0 to 12 hoursHSK21542 vs Placebo | 92.7% | 82.7% | P < 0.001 |
| Rescue doses · 0 to 12 hoursHSK21542 vs Placebo | 0.00 (IQR 0.00–1.00) | 1.00 (IQR 0.00–2.00) | P < 0.001 |
| Rescue doses · 0 to 24 hoursHSK21542 vs Placebo | 0.00 (IQR 0.00–1.00) | 1.00 (IQR 0.00–2.00) | P < 0.001 |
Rescue doses, HSK21542 vs tramadol · 0 to 12 and 0 to 24 hours
- No significant differences with tramadol
Safety
| Outcome | HSK21542 | Tramadol |
|---|---|---|
| Nausea | 24.7% | 66.7% |
| Vomiting | 21.3% | 60.5% |
| Dizziness | — not stated in the abstract | 1 events |
— not stated in the abstract
- Nausea: significantly lower with HSK21542
- Vomiting: significantly lower with HSK21542
Original publication
HSK21542 for Postoperative Analgesia in Gynecological Surgery: A Pooled Post-Hoc Analysis of Two Phase III Randomized Controlled Trials. Anesth Analg. Published 23 March 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →