Gao Zhengzheng, Zhang Jianmin, Nie Xiaolu, Cui Xiaohuan
Department of Anesthesiology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, People's Republic of China.
Center for Clinical Epidemiology and Evidence-based Medicine, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, People's Republic of China.
J Pain Res. 2022 May 12;15:1401-1410. doi: 10.2147/JPR.S363110. eCollection 2022.
Emergence agitation (EA) has a negative effect on the recovery from general anesthesia in children. This study aimed to evaluate the effectiveness of intravenous ibuprofen in reducing the incidence of EA in children.
This randomized, double-blind, placebo-controlled, single-center study analyzed data from patients aged 3-9 years undergoing tonsillectomy under general anesthesia with propofol and remifentanil. These patients were randomly assigned to receive either the ibuprofen or the placebo intraoperatively. The primary endpoint was a between-group difference in the incidence of EA at 15 min following extubation. EA was defined as Pediatric Anesthesia Emergence Delirium score ≥10. The secondary endpoint included the associated factors of EA.
Eighty-nine patients were included in the study. Ibuprofen decreased the incidence of EA at 15 min following extubation (8.9% in the treatment group vs 34.1% in the control group; odds ratio [OR], 0.261; 95% confidence interval [CI], 0.094-0.724; =0.004). Compared with the control group, there was a significant reduction in the number of rescue fentanyl doses (=0.045), and fewer patients experienced moderate to severe pain at 15 min following extubation in the treatment group (=0.048). Upon logistic regression analysis, high modified Pediatric Anesthesia Behavior and pain scores following surgery were considered the risk factors related to EA (OR, 8.07; 95% CI, 1.12-58.07, =0.038 and OR, 2.78; 95% CI, 1.60-4.82, <0.001, respectively). Ibuprofen administration was the protective factor related to EA (OR, 0.05; 95% CI, 0.01-0.67, =0.023).
Intraoperative ibuprofen infusion can significantly reduce the incidence of EA following general anesthesia with propofol and remifentanil in children.
The study was registered with the Chinese Clinical Trial Registry on 7 April 2021 (number: ChiCTR2100045128; https://www.chictr.org.cn/edit.aspx?pid=124595&htm=4).
苏醒期躁动（EA）对儿童全身麻醉后的恢复有负面影响。本研究旨在评估静脉注射布洛芬降低儿童EA发生率的有效性。
本随机、双盲、安慰剂对照、单中心研究分析了3至9岁在丙泊酚和瑞芬太尼全身麻醉下接受扁桃体切除术患者的数据。这些患者术中被随机分配接受布洛芬或安慰剂。主要终点是拔管后15分钟时两组之间EA发生率的差异。EA定义为小儿麻醉苏醒期谵妄评分≥10分。次要终点包括EA的相关因素。
89例患者纳入研究。布洛芬降低了拔管后15分钟时EA的发生率（治疗组为8.9%，对照组为34.1%；比值比[OR]为0.261；95%置信区间[CI]为0.094 - 0.724；P = 0.004）。与对照组相比，抢救用芬太尼剂量显著减少（P = 0.045），治疗组拔管后15分钟时经历中度至重度疼痛的患者更少（P = 0.048）。经逻辑回归分析，术后改良小儿麻醉行为和疼痛评分高被认为是与EA相关的危险因素（OR分别为8.07；95%CI为1.12 - 58.07，P = 0.038和OR为2.78；95%CI为1.60 - 4.82，P < 0.001）。布洛芬给药是与EA相关的保护因素（OR为0.05；95%CI为0.01 - 0.67，P = 0.023）。
术中静脉输注布洛芬可显著降低儿童在丙泊酚和瑞芬太尼全身麻醉后的EA发生率。
该研究于2021年4月7日在中国临床试验注册中心注册（注册号：ChiCTR2100045128；https://www.chictr.org.cn/edit.aspx?pid=124595&htm=4）。
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