右酮洛芬氨丁三醇注射液治疗术后疼痛的有效性和安全性的随机、双盲、与安慰剂平行对照的多中心临床研究
[Translation] A randomized, double-blind, placebo-controlled, multicenter clinical study on the efficacy and safety of dexketoprofen tromethamine injection in the treatment of postoperative pain
1) 主要目的:通过术后24h吗啡用量来证明右酮洛芬氨丁三醇治疗术后疼痛的有效性. 2) 次要目的:通过各时间段患者VAS评分、使用补救药物的患者比例、PCA按压次数等从其他方面证明右酮洛芬氨丁三醇治疗术后疼痛的有效性,以及通过不良反应的发生率来证明右酮洛芬氨丁三醇的安全性。
[Translation] 1) Primary objective: To demonstrate the effectiveness of dexketoprofen tromethamine in the treatment of postoperative pain by measuring the morphine consumption within 24 hours after surgery. 2) Secondary objective: To demonstrate the effectiveness of dexketoprofen tromethamine in the treatment of postoperative pain by measuring the VAS scores of patients at different time periods, the proportion of patients using rescue medication, the number of PCA compressions, and other aspects, and to demonstrate the safety of dexketoprofen tromethamine by measuring the incidence of adverse reactions.
[Translation] Study on the pharmacokinetics of dexketoprofen tromethamine injection in healthy volunteers
单次恒速静脉输注右酮洛芬氨丁三醇注射液50 mg,采集血样和尿样进行检测。考察静脉输注药品给药方式与操作流程、采血时间点等设置的合理性,为正式试验提供依据;验证血浆药物浓度和尿样中药物浓度分析方法。
[Translation] A single constant-rate intravenous infusion of 50 mg of dexketoprofen tromethamine injection was performed, and blood and urine samples were collected for testing. The rationality of the intravenous infusion drug administration method, operation process, blood collection time point, etc. was investigated to provide a basis for formal trials; the analysis method of drug concentration in plasma and urine samples was verified.
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