静脉注射布洛芬与酮咯酸用于小儿下腹部手术后镇痛的比较：一项随机、对照、非劣效性研究。

Comparison of intravenous ibuprofen versus ketorolac for postoperative analgesia in children undergoing lower abdominal surgery: A randomized, controlled, non-inferiority study.

机构信息

Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Mansoura, Egypt.

出版信息

Rev Esp Anestesiol Reanim (Engl Ed). 2022 Oct;69(8):463-471. doi: 10.1016/j.redare.2022.08.008. Epub 2022 Sep 7.

DOI:10.1016/j.redare.2022.08.008

PMID:36088270

Abstract

BACKGROUND

Non-steroidal anti-inflammatory drugs are often used as part of multimodal analgesia to control postoperative pain. This randomized, controlled, double-blinded, non-inferiority study aimed to compare the postoperative analgesic effects of intravenous ibuprofen versus ketorolac in children undergoing open unilateral lower abdominal surgery. The authors hypothesized that postoperative analgesia produced by intravenous ibuprofen would be non-inferior to that of intravenous ketorolac.

METHODS

Sixty-six children aged 2 to 8 years who were scheduled to undergo unilateral lower abdominal surgery, were recruited. Patients in the ibuprofen group received 10mg/kg/6h intravenous ibuprofen. Patients in the ketorolac group were given 0.5mg/kg/6h intravenous ketorolac. The primary outcome measure was 24-h postoperative morphine consumption. The secondary outcome measures were postoperative pain score, the incidence of early postoperative fever and the incidence of ibuprofen and ketorolac adverse effects including pain during drug infusion, vomiting, epigastric pain and allergic reaction.

RESULTS

Fifty-nine patients completed the study (30 ibuprofen, 29 ketorolac). There was no significant difference (P=0.305) in the mean (SD) 24-h postoperative morphine consumption (μ/kg) between intravenous ibuprofen, 16.00 (5.31), and ketorolac, 14.65 (4.61). The reported pain scores were similar in both groups. The incidence of postoperative fever was significantly lower (p=0.039) in the ibuprofen group (3%) than the ketorolac group (20%). The incidence of adverse effects was similar in both ibuprofen and ketorolac groups.

CONCLUSIONS

Intravenous ibuprofen can be used as an alternative to ketorolac for postoperative analgesia in children undergoing unilateral lower abdominal surgery because both drugs similarly provide safe and effective postoperative analgesia.

摘要

背景

非甾体类抗炎药常作为多模式镇痛的一部分，用于控制术后疼痛。本随机、对照、双盲、非劣效性研究旨在比较静脉用布洛芬与酮洛酸在接受单侧下腹部开放性手术的儿童中的术后镇痛效果。作者假设静脉用布洛芬产生的术后镇痛效果不亚于静脉用酮洛酸。

方法

招募了 66 名年龄在 2 至 8 岁之间计划接受单侧下腹部手术的儿童。布洛芬组患者接受 10mg/kg/6h 静脉用布洛芬。酮洛酸组患者给予 0.5mg/kg/6h 静脉用酮洛酸。主要结局指标为 24 小时术后吗啡消耗量。次要结局指标为术后疼痛评分、早期术后发热发生率以及布洛芬和酮洛酸不良反应的发生率，包括输注过程中疼痛、呕吐、上腹痛和过敏反应。

结果

59 名患者完成了研究（布洛芬组 30 名，酮洛酸组 29 名）。静脉用布洛芬（16.00[5.31]μ/kg）和酮洛酸（14.65[4.61]μ/kg）的 24 小时术后吗啡消耗量（μ/kg）均值差异无统计学意义（P=0.305）。两组的报告疼痛评分相似。布洛芬组（3%）术后发热发生率明显低于酮洛酸组（20%）（p=0.039）。布洛芬组和酮洛酸组的不良反应发生率相似。