[Translation] A randomized, double-blind, placebo-controlled, multicenter clinical study on the efficacy and safety of ibuprofen injection in the treatment of moderate to severe postoperative pain
1、以术后24h内吗啡总用量为主要疗效指标,以安慰剂为对照,评价布洛芬注射液辅助治疗腔镜(单个切口≥5公分)、腹部或骨科术后中、重度疼痛的有效性; 2、通过实验室检查、临床症状、体征、不良事件/严重不良事件等,评价布洛芬注射液的安全性。
[Translation] 1. To evaluate the effectiveness of ibuprofen injection in the adjuvant treatment of moderate to severe pain after laparoscopic (single incision ≥ 5 cm), abdominal or orthopedic surgery, using the total amount of morphine used within 24 hours after surgery as the primary efficacy indicator and placebo as the control; 2. To evaluate the safety of ibuprofen injection through laboratory tests, clinical symptoms, signs, adverse events/serious adverse events, etc.