Intranasal Dexmedetomidine-Esketamine Combination Premedication versus Monotherapy for Reducing Emergence Delirium and Postoperative Behavioral Changes in Pediatric Tonsillectomy and/or Adenoidectomy: A Randomized Controlled Trial.

IF 4.7 2区医学 Q1 CHEMISTRY, MEDICINAL

Drug Design, Development and Therapy Pub Date : 2024-10-23 eCollection Date: 2024-01-01 DOI:10.2147/DDDT.S488706

Yanling Liao, Siyu Xie, Yifen Zhuo, Sisi Chen, Yuxin Luo, Ying Wei, Yusheng Yao

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引用次数: 0

Abstract

Purpose: Emergence delirium and postoperative negative behavioral changes (PNBC) are common complications in pediatric anesthesia. This study evaluated whether intranasal premedication combining dexmedetomidine and esketamine more effectively reduces these complications compared to either drug alone in children undergoing tonsillectomy and/or adenoidectomy with sevoflurane anesthesia.

Patients and methods: This randomized, double-blind trial involved 198 children aged 2-5 years undergoing tonsillectomy and/or adenoidectomy. Participants received intranasal premedication with either dexmedetomidine (2 μg/kg), esketamine (1 mg/kg), or their combination (dexmedetomidine 1 μg/kg plus esketamine 0.5 mg/kg). The primary outcome was the incidence of emergence delirium, defined as a Pediatric Anesthesia Emergence Delirium (PAED) scale score ≥ 10. Secondary outcomes included the incidence of PNBC, sedation depth, easiness of separation from parents, acceptance of the mask for induction, emergence time, postoperative pain score, parental satisfaction, and adverse events.

Results: The combination premedication significantly reduced emergence delirium incidence (9.4%) compared to esketamine alone (38.1%; relative risk [RR] 0.25, 95% confidence interval [CI] 0.11-0.57, p < 0.001), but not compared to dexmedetomidine alone (17.2%; RR 0.55, 95% CI 0.21-1.39, p = 0.193). PNBC incidence at day 7 was lower with the combination (28.1%) versus dexmedetomidine (48.4%; RR 0.58, 95% CI 0.36-0.93, p = 0.018), but not significantly different from esketamine alone (20.6%; RR 1.38, 95% CI 0.74-2.58, p = 0.326). The combination also provided significantly superior sedation, improved ease of separation from parents, better acceptance of the mask for induction, shorter emergence time, and higher parental satisfaction than both monotherapies.

Conclusion: In children undergoing tonsillectomy and/or adenoidectomy with sevoflurane anesthesia, intranasal dexmedetomidine-esketamine premedication more effectively reduces emergence delirium compared to esketamine alone and PNBC compared to dexmedetomidine alone. This combination also improves sedation, shortens emergence times, and enhances parental satisfaction compared to monotherapy without significant adverse effects.

Trial registration: The Chinese Clinical Trial Registry, ChiCTR2300076709.

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鼻内右美托咪定-艾司西塔明联合术前用药与单药治疗在减少小儿扁桃体切除术和/或腺样体切除术术后谵妄和术后行为变化方面的比较：随机对照试验。

目的：谵妄和术后不良行为改变（PNBC）是小儿麻醉中常见的并发症。本研究评估了在使用七氟醚麻醉进行扁桃体切除术和/或腺样体切除术的儿童中，与单独使用其中一种药物相比，结合右美托咪定和艾司氯胺酮的鼻内预处理是否能更有效地减少这些并发症：这项随机双盲试验涉及 198 名接受扁桃体切除术和/或腺样体切除术的 2-5 岁儿童。参加者接受了右美托咪定（2 μg/kg）、艾司卡胺（1 mg/kg）或它们的组合（右美托咪定 1 μg/kg 加艾司卡胺 0.5 mg/kg）的鼻内预处理。主要结果是谵妄发生率，即小儿麻醉谵妄（PAED）量表评分≥10。次要结果包括 PNBC 的发生率、镇静深度、与父母分离的难易程度、对诱导面罩的接受程度、出现时间、术后疼痛评分、父母满意度和不良事件：与单独使用艾司卡胺（38.1%；相对风险[RR]0.25，95%置信区间[CI]0.11-0.57，p <0.001）相比，联合预处理可明显降低出现谵妄的发生率（9.4%），但与单独使用右美托咪定（17.2%；RR 0.55，95%置信区间[CI]0.21-1.39，p = 0.193）相比，联合预处理并不能降低出现谵妄的发生率。与右美托咪定（48.4%；RR 0.58，95% CI 0.36-0.93，p = 0.018）相比，联合用药第7天的PNBC发生率较低（28.1%），但与单用埃斯卡敏（20.6%；RR 1.38，95% CI 0.74-2.58，p = 0.326）相比无显著差异。与两种单一疗法相比，联合疗法的镇静效果明显更好，更容易与父母分离，更容易接受面罩诱导，出院时间更短，父母满意度更高：结论：在使用七氟醚麻醉进行扁桃体切除术和/或腺样体切除术的儿童中，与单独使用埃斯卡胺相比，鼻内右美托咪定-埃斯卡胺预处理能更有效地减少出院谵妄，与单独使用右美托咪定相比，鼻内右美托咪定-埃斯卡胺预处理能更有效地减少出院谵妄，与单独使用右美托咪定相比，鼻内右美托咪定-埃斯卡胺预处理能更有效地减少出院谵妄。与单药治疗相比，这种联合用药还能改善镇静、缩短出院时间并提高家长满意度，且无明显不良反应：试验注册：中国临床试验注册中心，ChiCTR2300076709。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Drug Design, Development and Therapy CHEMISTRY, MEDICINAL-PHARMACOLOGY & PHARMACY

CiteScore

9.00

自引率

0.00%

发文量

382

审稿时长

>12 weeks

期刊介绍： Drug Design, Development and Therapy is an international, peer-reviewed, open access journal that spans the spectrum of drug design, discovery and development through to clinical applications. The journal is characterized by the rapid reporting of high-quality original research, reviews, expert opinions, commentary and clinical studies in all therapeutic areas. Specific topics covered by the journal include: Drug target identification and validation Phenotypic screening and target deconvolution Biochemical analyses of drug targets and their pathways New methods or relevant applications in molecular/drug design and computer-aided drug discovery* Design, synthesis, and biological evaluation of novel biologically active compounds (including diagnostics or chemical probes) Structural or molecular biological studies elucidating molecular recognition processes Fragment-based drug discovery Pharmaceutical/red biotechnology Isolation, structural characterization, (bio)synthesis, bioengineering and pharmacological evaluation of natural products** Distribution, pharmacokinetics and metabolic transformations of drugs or biologically active compounds in drug development Drug delivery and formulation (design and characterization of dosage forms, release mechanisms and in vivo testing) Preclinical development studies Translational animal models Mechanisms of action and signalling pathways Toxicology Gene therapy, cell therapy and immunotherapy Personalized medicine and pharmacogenomics Clinical drug evaluation Patient safety and sustained use of medicines.