关于“右美托咪定鼻内给药与艾司氯胺酮鼻内给药用于幼儿程序性镇静和镇痛的随机双盲试验”的评论
Comment on "A randomized double-blind trial of intranasal dexmedetomidine versus intranasal esketamine for procedural sedation and analgesia in young children".
作者信息
Wang Jiajing
机构信息
Department of Anesthesiology, Nanfang Hospital, Southern Medical University, The key Laboratory of Precision Anesthesia & perioperative Organ Protection, Guangzhou, 510515, Guangdong, China.
Department of Anesthesiology, Zengcheng Campus Nanfang Hospital, Southern Medical University, Guangzhou, 511338, Guangdong, China.
出版信息
Scand J Trauma Resusc Emerg Med. 2025 May 13;33(1):84. doi: 10.1186/s13049-025-01403-5.
Abstract
This comment critiques a trial comparing intranasal dexmedetomidine (DEX) and esketamine (sKET) for pediatric procedural sedation. Despite a large effect size, the small sample (n = 29) likely caused false-negative results (p = 0.09), necessitating larger trials. Safety concerns (e.g., aspiration risk), unaddressed long-term psychological outcomes, and limited pharmacokinetic data (delayed DEX onset, prolonged duration) challenge clinical applicability. Future studies should integrate objective measures and long-term follow-up.
摘要
本评论对一项比较鼻内给予右美托咪定（DEX）和艾司氯胺酮（sKET）用于儿科程序性镇静的试验进行了批评。尽管效应量较大，但小样本量（n = 29）可能导致了假阴性结果（p = 0.09），因此需要进行更大规模的试验。安全问题（如误吸风险）、未解决的长期心理结果以及有限的药代动力学数据（DEX起效延迟、持续时间延长）对临床适用性提出了挑战。未来的研究应纳入客观测量和长期随访。
相似文献
1
Comment on "A randomized double-blind trial of intranasal dexmedetomidine versus intranasal esketamine for procedural sedation and analgesia in young children".关于“右美托咪定鼻内给药与艾司氯胺酮鼻内给药用于幼儿程序性镇静和镇痛的随机双盲试验”的评论
Scand J Trauma Resusc Emerg Med. 2025 May 13;33(1):84. doi: 10.1186/s13049-025-01403-5.
2
Comparison of combined intranasal dexmedetomidine and ketamine versus chloral hydrate for pediatric procedural sedation: a randomized controlled trial.小儿程序性镇静中鼻内联合使用右美托咪定和氯胺酮与水合氯醛的比较：一项随机对照试验。
Korean J Anesthesiol. 2025 Jun;78(3):248-260. doi: 10.4097/kja.24815. Epub 2025 Apr 4.
3
Efficacy of intranasal dexmedetomidine-esketamine sedation for pediatric acceptance of facemask: single-center, double-blind, randomized, controlled trial.鼻内给予右美托咪定-艾司氯胺酮镇静用于小儿接受面罩的效果：单中心、双盲、随机对照试验
BMC Anesthesiol. 2025 Feb 11;25(1):66. doi: 10.1186/s12871-025-02939-w.
4
The sedative effects of the intranasal administration of dexmedetomidine in children undergoing surgeries compared to other sedation methods: A systematic review and meta-analysis.鼻腔内给予右美托咪定与其他镇静方法相比在儿童手术中镇静效果的系统评价和荟萃分析。
J Clin Anesth. 2017 May;38:33-39. doi: 10.1016/j.jclinane.2017.01.014. Epub 2017 Jan 15.
5
Chloral hydrate as a sedating agent for neurodiagnostic procedures in children.水合氯醛作为镇静剂在儿科神经诊断中的应用。
Cochrane Database Syst Rev. 2021 Aug 16;8(8):CD011786. doi: 10.1002/14651858.CD011786.pub3.
6
Effects of Intranasal dexmedetomidine and esketamine for premedication on postoperative pain after tonsillectomy and adenoidectomy in children: a randomized clinical trial.鼻内右美托咪定和艾司氯胺酮术前用药对儿童扁桃体切除术和腺样体切除术后疼痛的影响：一项随机临床试验。
BMC Anesthesiol. 2025 Jul 1;25(1):330. doi: 10.1186/s12871-025-03203-x.
7
Intranasal dexmedetomidine versus intranasal midazolam as a standard of care for pediatric patients undergoing transcatheter perimembranous ventricular septal defect (VSD) closure: a randomized controlled trial.经导管膜周部室间隔缺损（VSD）封堵术的儿科患者中，鼻内给予右美托咪定与鼻内给予咪达唑仑作为标准治疗的比较：一项随机对照试验。
Anaesthesiol Intensive Ther. 2025 Jun 17;57(1):115-120. doi: 10.5114/ait/200231.
8
A randomized clinical trial of intranasal dexmedetomidine versus inhaled nitrous oxide for procedural sedation and analgesia in children.一项比较鼻内给予右美托咪定和吸入一氧化二氮用于儿童操作镇静和镇痛的随机临床试验。
Scand J Trauma Resusc Emerg Med. 2024 Nov 20;32(1):117. doi: 10.1186/s13049-024-01292-0.
9
Chloral hydrate as a sedating agent for neurodiagnostic procedures in children.水合氯醛作为儿童神经诊断程序中的镇静剂。
Cochrane Database Syst Rev. 2017 Nov 3;11(11):CD011786. doi: 10.1002/14651858.CD011786.pub2.
10
Comparison of plasma concentration and sedative effect of sublingual and intranasal dexmedetomidine in children: A double-blind randomised controlled study.儿童舌下含服与鼻内给予右美托咪定的血药浓度及镇静效果比较：一项双盲随机对照研究。
Acta Anaesthesiol Scand. 2025 Mar;69(3):e14583. doi: 10.1111/aas.14583.
本文引用的文献
1
A randomized double-blind trial of intranasal dexmedetomidine versus intranasal esketamine for procedural sedation and analgesia in young children.一项比较鼻内用右美托咪定与鼻内用依托咪酯用于小儿镇静镇痛的随机双盲试验。
Scand J Trauma Resusc Emerg Med. 2024 Mar 4;32(1):16. doi: 10.1186/s13049-024-01190-5.
2
Optimal Dose of Intranasal Dexmedetomidine for Laceration Repair in Children: A Phase II Dose-Ranging Study.鼻腔内给予右美托咪定用于儿童裂伤修复的最佳剂量：一项 II 期剂量范围研究。
Ann Emerg Med. 2023 Aug;82(2):179-190. doi: 10.1016/j.annemergmed.2023.01.023. Epub 2023 Mar 3.
3
Fundamental Statistical Concepts in Clinical Trials and Diagnostic Testing.临床试验与诊断测试中的基本统计概念
J Nucl Med. 2021 Jun 1;62(6):757-764. doi: 10.2967/jnumed.120.245654. Epub 2021 Feb 19.
4
Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures.儿科患者镇静诊断和治疗程序前、中、后监测和管理指南。
Pediatrics. 2019 Jun;143(6). doi: 10.1542/peds.2019-1000.
5
Innovations in Mixed Methods Evaluations.混合方法评估的创新。
Annu Rev Public Health. 2019 Apr 1;40:423-442. doi: 10.1146/annurev-publhealth-040218-044215. Epub 2019 Jan 11.
6
Does intranasal dexmedetomidine provide adequate plasma concentrations for sedation in children: a pharmacokinetic study.鼻腔内给予右美托咪定能否为儿童镇静提供足够的血浆浓度：一项药代动力学研究。
Br J Anaesth. 2018 May;120(5):1056-1065. doi: 10.1016/j.bja.2018.01.035. Epub 2018 Mar 13.
7
The influence of children's pain memories on subsequent pain experience.儿童疼痛记忆对后续疼痛体验的影响。
Pain. 2012 Aug;153(8):1563-1572. doi: 10.1016/j.pain.2012.02.020. Epub 2012 May 3.
8
Consequences of inadequate analgesia during painful procedures in children.儿童疼痛性操作期间镇痛不足的后果。
Arch Pediatr Adolesc Med. 1998 Feb;152(2):147-9. doi: 10.1001/archpedi.152.2.147.
Zotero 插件