[Translation] A randomized, double-blind, double-dummy, parallel-controlled multi-center clinical study evaluating ketorolac tromethamine injection in the treatment of postoperative pain with tramadol as control
通过多中心、随机、双盲双模、阳性对照的临床研究,评价该产品用于手术后疼痛的安全性和有效性。通过与盐酸曲马多对照试验用于治疗手术后急性疼痛,对该产品的临床疗效进行评价。通过观察血、尿、大便常规及潜血,心电图,肝功能(ALT、AST)、肾功能(BUN、Cr)、凝血功能(PT、APTT)及可能出现的不良反应,对其安全性作出评价。
[Translation] Through a multi-center, randomized, double-blind, double-mode, positive-controlled clinical study, the safety and efficacy of the product for postoperative pain were evaluated. The clinical efficacy of this product was evaluated through a controlled trial with tramadol hydrochloride for the treatment of acute postoperative pain. The safety was evaluated by observing routine blood, urine, stool and occult blood, electrocardiogram, liver function (ALT, AST), renal function (BUN, Cr), coagulation function (PT, APTT) and possible adverse reactions.