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褪黑素与右美托咪定用于儿童脑电图检查前诱导睡眠的比较。

Melatonin vs. dexmedetomidine for sleep induction in children before electroencephalography.

作者信息

Peganc Nunčič Katja, Neubauer David, Oražem Mrak Jasna, Perković Benedik Mirjana, Mahne Urška, Bizjak Neli, Rener Primec Zvonka, Šuštar Nataša, Butenko Tita, Vrščaj Eva, Osredkar Damjan

机构信息

Department of Pediatric Neurology, University Children's Hospital, University Medical Centre Ljubljana, Ljubljana, Slovenia.

Faculty of Medicine, Center for Developmental Neuroscience, University of Ljubljana, Ljubljana, Slovenia.

出版信息

Front Pediatr. 2024 Apr 25;12:1362918. doi: 10.3389/fped.2024.1362918. eCollection 2024.

Abstract

BACKGROUND AND OBJECTIVES

In children requiring electroencephalography (EEG), sleep recording can provide crucial information. As EEG recordings during spontaneous sleep are not always possible, pharmacological sleep-inducing agents are sometimes required. The aim of the study was to evaluate safety and efficacy of melatonin (Mel) and dexmedetomidine (Dex; intranasal and sublingual application) for sleep induction prior to EEG.

METHODS

In this prospective randomized study, 156 consecutive patients aged 1-19 years were enrolled and randomized by draw into melatonin group (Mel;  = 54; dose: 0.1 mg/kg), dexmedetomidine (Dex) sublingual group (DexL;  = 51; dose: 3 mcg/kg) or dexmedetomidine intranasal group (DexN;  = 51; dose: 3 mcg/kg). We compared the groups in several parameters regarding efficacy and safety and also carried out a separate analysis for a subgroup of patients with complex behavioral problems.

RESULTS

Sleep was achieved in 93.6% of participants after the first application of the drug and in 99.4% after the application of another if needed. Mel was effective as the first drug in 83.3% and Dex in 99.0% ( < 0.001); in the subgroup of patients with complex developmental problems Mel was effective in 73.4% and Dex in 100% ( < 0.001). The patients fell asleep faster after intranasal application of Dex than after sublingual application ( = 0.006). None of the patients had respiratory depression, bradycardia, desaturation, or hypotension.

CONCLUSIONS

Mel and Dex are both safe for sleep induction prior to EEG recording in children. Dex is more effective compared to Mel in inducing sleep, also in the subgroup of children with complex behavioral problems.

CLINICAL TRIAL REGISTRATION

Dexmedetomidine and Melatonin for Sleep Induction for EEG in Children, NCT04665453.

摘要

背景与目的

对于需要进行脑电图(EEG)检查的儿童,睡眠记录可提供关键信息。由于在自然睡眠期间进行EEG记录并非总是可行,有时需要使用药物诱导睡眠。本研究的目的是评估褪黑素(Mel)和右美托咪定(Dex;鼻内和舌下给药)在EEG检查前诱导睡眠的安全性和有效性。

方法

在这项前瞻性随机研究中,连续纳入156例年龄在1至19岁的患者,并通过抽签随机分为褪黑素组(Mel;n = 54;剂量:0.1mg/kg)、右美托咪定舌下给药组(DexL;n = 51;剂量:3mcg/kg)或右美托咪定鼻内给药组(DexN;n = 51;剂量:3mcg/kg)。我们比较了各组在疗效和安全性方面的几个参数,并对有复杂行为问题的患者亚组进行了单独分析。

结果

首次用药后93.6%的参与者实现了睡眠,如有需要再次用药后99.4%的参与者实现了睡眠。Mel作为首次用药的有效率为83.3%,Dex为99.0%(P < 0.001);在有复杂发育问题的患者亚组中,Mel的有效率为73.4%,Dex为100%(P < 0.001)。鼻内应用Dex后患者入睡速度比舌下应用更快(P = 0.006)。没有患者出现呼吸抑制、心动过缓、血氧饱和度降低或低血压。

结论

Mel和Dex在儿童EEG记录前诱导睡眠均安全。与Mel相比,Dex在诱导睡眠方面更有效,在有复杂行为问题的儿童亚组中也是如此。

临床试验注册

儿童EEG睡眠诱导用右美托咪定和褪黑素,NCT04665453。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c1a4/11079286/463ffcd9479b/fped-12-1362918-g001.jpg

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