地佐辛用于儿童术后镇痛有效性和安全性的随机对照试验  

Efficacy and safety of dezocine for postoperative analgesia in children:A randomized controlled trial

作　　者：邓迎 皮丹丹[1] 刘成军[1] 李静[1] 符跃强[1] 许峰[1] DENG Ying;PI Dandan;LIU Chengjun;LI Jing;FU Yueqiang;XU Feng(Pediatric Intensive Care Unit,Children's Hospital of Chongqing Medical University,Ministry of Education Key Laboratory of Child Development and Disorders,Nationa Clinical Research Center for Child Health and Disorders,International Science and Technology Cooperation base of Child development and Critical Disorders orders,Chongqing Key Laboratory of Pediatrics,Chongqing 400014,China)

机构地区：[1]重庆医科大学附属儿童医院重症医学科,儿童发育疾病研究教育部重点实验室,国家儿童健康与疾病临床医学研究中心,儿童发育重大疾病国家国际科技合作基地,儿科学重庆市重点实验室,重庆400014

出　　处：《中国循证儿科杂志》2023年第1期27-31,共5页Chinese Journal of Evidence Based Pediatrics

摘　　要：背景新型阿片受体激动-拮抗剂地佐辛用于儿童术后镇痛的研究报道甚少,且没有公认的儿童用药参考剂量。目的探讨地佐辛应用于儿童术后镇痛的有效性和安全性,为其用于儿童术后镇痛提供合适的参考剂量。设计单中心RCT。方法纳入在重庆医科大学附属儿童医院行先天性心脏病(CHD)手术后直接转入PICU的患儿,手术时年龄>28 d,术前美国麻醉医师协会(ASA)分级Ⅲ~Ⅳ级。按随机数字表法生成随机分组方案,装入密闭信封保存;由当班的PICU医生负责入组,由管床护士执行干预。随机分为5组,试验组患儿在术后持续静脉泵入低剂量(D1组)、中剂量(D2组)或高剂量(D3组)地佐辛,对照组泵入舒芬太尼(SF组)或吗啡(M组),观察术后疼痛评分和镇静评分。未对结局指标观察人员和数据分析人员施盲。共同干预措施:入PICU后使用有创呼吸机辅助通气,予对症处理和咪达唑仑镇静。D1、D2、D3组分别予地佐辛20、30、40μg·kg^(-1)·h^(-1),SF组予舒芬太尼0.08μg·kg^(-1)·h^(-1),M组予吗啡20μg·kg^(-1)·h^(-1),均为静脉泵注。疼痛评分包括脸谱疼痛评分法(FPS)和CRIES评分法,镇静评分包括Ramsay评分法和舒适行为量表(Comfort-B评分),均由PICU专科护士完成。主要结局指标术后1 h、4 h、8 h、12 h和24 h的镇痛/镇静满意度百分比。结果共152例CHD患儿入组,D1、D2、D3、SF和M组分别为30、30、31、31和30例,均完成设计的干预和观察。5组患儿年龄、体重、性别、体外循环时间、危重症评分(PCIS)和术前ASA分级差异均无统计学意义。①FPS评分:D2组术后24 h,D3组术后4 h、24 h镇痛满意度高于M组;CRIES评分:D1、D2组术后1 h、4 h,D3组术后4 h、24 h镇痛满意度高于M组;Ramsay评分:D2、D3组术后1 h、4 h镇静满意度高于M组;Comfort-B评分:D1组术后4 h、12 h,D2组术后1 h、4 h,D3组术后1 h、4 h、12 h镇静满意度高于M组;差异均有统计学意义。4种评分DBackground The use of dezocine,a new opioid agonist-antagonist,for postoperative analgesia in children is poorly reported,and there is no accepted reference dose for its use in children.Objective To investigate the efficacy and safety of dezocine in postoperative analgesia in children,and to provide a suitable reference dose for analgesia in postoperative children.Design Single-center randomized controlled study.Methods With the preoperative classification ofⅢ-Ⅳby the American Society of Anesthesiologists(ASA),patients directly transferred to PICU after congenital heart disease(CHD)were enrolled from Children's Hospital of Chongqing Medical University at the age of>28 d at the time of surgery.A random number table was used and the grouping results were sealed in an envelope.The PICU physician on duty was responsible for the subject assignment,and the bedside nurse performed the intervention.All patients were randomized into 5 groups.Subjects in the experimental group were continuously injected with low-dose(group D1),medium-dose(group D2),or high-dose(group D3)dezocine after the operation,and those in the control group were injected with sufentanil(group SF)or morphine(group M).The postoperative pain and sedation scores were observed.The outcome observers and data analysts were not blinded.Invasive ventilator-assisted ventilation,symptomatic management,and midazolam sedation were performed after admission to the PICU in both five groups.D1,D2,and D3 groups received dezocine 20,30,40μg·kg^(-1)·h^(-1) respectively,SF group received sufentanil 0.08μg·kg^(-1)·h^(-1),and M group received morphine 20μg·kg^(-1)·h^(-1).All intravenous injection was administrated through a syringe pump.Face Pain Scale(FPS)and Child Revised Impact of Events Scale(CRIES)were used to evaluate pain,and Ramsay and Comfort-B were used to score sedation.All scales were completed by PICU specialist nurses.Main outcome measures The percentage of satisfaction with analgesia/sedation at 1 h,4 h,8 h,12 h,and 24 h after the operation.Resu

关 键 词：地佐辛 儿童 镇痛 镇静 

分 类 号：R726.1[医药卫生—儿科]