右酮洛芬氨丁三醇与氟比洛芬酯在妇科日间手术术后镇痛的临床研究OA

Objective To compare the non-inferiority of dexketoprofen trometamol injection versus flurbiprofen axetil injection for postoperative analgesia in minor gynecological day surgery.Methods This was a single-center,prospective,randomized,double-blind,active-controlled,parallel-group,non-inferiority trial.Patients[American Society of Anesthesiologists(ASA)Ⅰ-Ⅱ]scheduled for elective minor gynecological day surgery were enrolled and randomly assigned into control group and treatment group.Patients in treatment group received intravenous dexketoprofen trometamol injection 50 mg,while those in control group received intravenous flurbiprofen axetil injection 50 mg,both administered 10 minutes before the end of surgery.The numerical rating scale(NRS)pain score at the time of discharge from the post-anesthesia care unit(PACU)with a non-inferiority margin set at 1.0 point,the Ramsay sedation scale(RSS),Richmond agitation-sedation scale(RASS),Bruggrmann comfort scale(BCS),rescue analgesic rate at PACU discharge and admission,as well as the quality of recovery-15(QoR-15)score and Richards-Campbell sleep questionnaire(RCSQ)score at 24 hours postoperatively were compared.Adverse events were also recorded.Results A total of 86 patients were enrolled,with 43 cases in each group.At PACU discharge,the NRS scores of the control group and the treatment group were 1.00(1.00,2.00)and 2.00(0,2.00),respectively;the 95％confidence interval(CI)for the Hodges-Lehmann median difference was(-1.00,0);as the upper bound of the 95％CI(0)fell below the non-inferiority margin of 1.00,non-inferiority was established.At PACU admission,the RSS scores of control and treatment group were 2.00(2.00,3.00)and 3.00(2.50,3.00),respectively;the RASS scores were 0(-1.00,0)and-1.00(-1.00,-0.50)scores,respectively;the NRS scores were 0(0,1.50)and 0(0,1.00)scores,respectively;the BCS scores were 3.00(2.00,4.00)and 3.00(2.00,4.00)scores,respectively;at PACU discharge,the RSS scroes were 2.00(2.00,2.00)and 2.00(2.00,2.00)scores,respectively;the RASS scores were 0(0,0)and 0(0,0)scores,respectively;the BCS scores were 2.00(2.00,3.50)and 2.00(2.00,4.00)scores,respectively;at 24 hours postoperatively,the QoR-15 scores were 132.00(111.00,141.00)and 133.00(120.00,140.00)scores,respectively;the RCSQ scores were 80.00(61.00,84.00)and 74.00(48.50,82.00)scores,respectively;the rescue analgesia rates during PACU stay were 16.28％(7 cases/43 cases)and 6.98％(3 cases/43 cases).Except the RSS scores and RASS scores at PACU admission,which showed statistically significant differences(both P＜0.05),the differences of above indicators were all not statistically significant(all P＞0.05).No adverse events requiring clinical intervention occurred in either group.Conclusion Dexketoprofen trometamol injection 50 mg is non-inferior to flurbiprofen axetil injection 50 mg for postoperative analgesia in minor gynecological day surgery as measured by NRS score at PACU discharge.The two agents are comparable in terms of comfort,recovery quality,and sleep scores,and both exhibit a favorable safety profile.Dexketoprofen trometamol injection can serve as an effective alternative for multimodal analgesia in gynecological day surgery.