艾司氯胺酮联合舒芬太尼用于小儿四肢骨折术后镇痛的临床研究  

Clinical trial of esketamine combined with sufentanil for postoperative analgesia in children with fracture of limbs

作　　者：张天宇 杜晶晶 李梦 李梦雅 李雪 陈莺 ZHANG Tian-yu;DU Jing-jing;LI Meng;LI Meng-ya;LI Xue;CHEN Ying(Department of Anesthesiology,Graduate Training Base of Lianyungang First People's Hospital of Jinzhou Medical University,Lianyungang 222000,Jiangsu Province,China;Department of Anesthesiology,Lianyungang Hospital Affiliated to Xuzhou Medical University,Lianyungang 222000,Jiangsu Province,China)

机构地区：[1]锦州医科大学连云港市第一人民医院研究生培养基地麻醉科,江苏连云港222000 [2]徐州医科大学附属连云港医院麻醉科,江苏连云港222000

出　　处：《中国临床药理学杂志》2024年第11期1551-1555,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的观察艾司氯胺酮注射液联合舒芬太尼注射液用于小儿骨折术后自控静脉镇痛(PCIA)的临床疗效及安全性。方法将拟行择期四肢骨折切开内固定术患儿随机分为对照组和试验组。对照组给予2μg·kg^(-1)舒芬太尼行PCIA;试验组给予1.0 mg·kg^(-1)艾司氯胺酮复合1.5μg·kg^(-1)舒芬太尼行PCIA。2组背景剂量:2 mL·h^(-1),单次剂量每次2 mL,锁定时间15 min,总量100 mL。比较2组患儿术后不同时间点的面部表情、腿部活动、活动度、哭闹和可安慰性评估量表(FLACC)评分及Ramsay镇静评分,术后48 h内镇痛药物使用量及PCIA按压次数,以及药物不良反应的发生情况。结果试验组入组40例,脱落1例,最终有39例纳入统计分析;对照组入组40例,脱落2例,最终有38例纳入统计分析。治疗后,试验组术后2、4、6、12、24、48 h的FLACC评分分别为(4.75±0.93)、(2.50±0.97)、(1.75±0.93)、(2.06±1.18)、(1.13±0.62)和(0.50±0.63)分,对照组分别为(6.13±1.13)、(3.80±1.21)、(2.87±0.64)、(3.47±1.13)、(1.87±0.92)和(1.27±0.80)分,在统计学上差异均有统计学意义(均P<0.05)。试验组和对照组术后2 h Ramsay镇静评分分别为(2.25±0.45)和(1.47±0.52)分,24 h内PCIA有效按压次数分别为(4.25±3.94)和(8.13±5.71)次,术后24 h内镇痛药物使用量分别为(52.38±9.11)和(61.47±12.82)mL,术后48 h内镇痛药物使用量分别为(88.81±14.31)和(94.60±5.93)mL,在统计学上差异均有统计学意义(均P<0.05)。2组患者的药物不良反应均以头晕和恶心呕吐为主。试验组和对照组的总药物不良反应发生率分别为53.85%和84.21%,在统计学上差异有统计学意义(P<0.05)。结论艾司氯胺酮注射液联合舒芬太尼注射液用于小儿骨折术后自控泵镇痛可降低术后疼痛强度,提高镇痛镇静效果,降低镇痛泵药物不良反应发生率。Objective To observe the clinical efficacy and safety of esketamine injection combined with sufentanil injection for patient-controlled intravenous analgesia(PCIA)after fracture surgery in children.Methods Children scheduled for elective limb fracture incision and internal fixation were randomly divided into control group and treatment group.The control group was given 2μg·kg^(-1)sufentanil for PCIA;the treatment group was given 1.0 mg·kg^(-1)esketamine combined with 1.5μg·kg^(-1)sufentanil for PCIA.Background dose of 2 groups:2 mL·h^(-1),single dose of 2 mL each time,locking time of 15 min,total volume of 100 mL.The facial expression,leg movement,mobility,crying,consolability scale(FLACC)scores and Ramsay sedation scores,analgesic drug consumption and PCIA compression times within 48 h afteroperation,and adverse drug reactions were compared between the two groups at different time points after operation.Results Forty subjects enrolled in the treatment group,1 dropped out,and 39 were finally included in the statisticalanalysis;40 subjects enrolled in the control group,2 dropped out,and 38 were finally included in the statisticalanalysis.After treatment,the FLACC scores of treatment group at 2,4,6,12,24 and 48 h after operation were(4.75±0.93),(2.50±0.97),(1.75±0.93),(2.06±1.18),(1.13±0.62)and(0.50±0.63)points,whichin control group were(6.13±1.13),(3.80±1.21),(2.87±0.64),(3.47±1.13),(1.87±0.92)and(1.27±0.80)points,and there were significant differences in the two groups(allP<0.05).The Ramsay sedationscores of treatment and control groups at 2 hours after operation were(2.25±0.45)and(1.47±0.52)points;thenumber of effective PCIA compressions within 24 hours was 4.25±3.94 and 8.13±5.71;the amount of analgesicdrugs used within 24 hours after surgery was(52.38±9.11)and(61.47±12.82)mL;the amount of analgesic drugsused within 48 hours after surgery was(88.81±14.31)and(94.60±5.93)mL,respectively;and the differenceswere statistically significant(allP<0.05).The adverse drug reactions of two groups

关 键 词：艾司氯胺酮注射液 舒芬太尼注射液 小儿骨科 术后镇痛 自控静脉镇痛 安全性评价 

分 类 号：R971.2[医药卫生—药品]