Department of Pharmacology and Toxicology, Radboud Institute for Health Sciences, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands.
Intensive Care and Department of Pediatric Surgery, Erasmus MC, Sophia Children's Hospital, Dr Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.
Paediatr Drugs. 2022 May;24(3):247-257. doi: 10.1007/s40272-022-00498-y. Epub 2022 Mar 28.
Dexmedetomidine is currently off-label for use in pediatric clinical care worldwide. Nevertheless, it is frequently prescribed to pediatric patients as premedication prior to induction of anesthesia or for procedural sedation. There is ample literature on the pharmacokinetics, efficacy and safety of dexmedetomidine in this vulnerable patient population, but there is a general lack of consensus on dosing. In this project, we aimed to use the standardized workflow of the Dutch Pediatric Formulary to establish best evidence-based pediatric dosing guidelines for dexmedetomidine as premedication and for procedural sedation.
The available literature on dexmedetomidine in pediatrics was reviewed in order to address the following three questions: (1) What is the right dose? (2) What is known about efficacy? (3) What is known about safety? Relevant literature was compiled into a risk-benefit analysis document. A team of clinical experts critically appraised the analysis and the proposed dosing recommendations.
Dexmedetomidine is most commonly administered via the intravenous or intranasal route. Clearance is age dependent, warranting higher doses in infants to reach similar exposure as in adults. Dexmedetomidine use results in satisfactory sedation at parent separation, adequate sedation and a favorable recovery profile. The safety profile is good and comparable to adults, with dose-related hemodynamic effects.
Following the structured approach of the Dutch Pediatric Formulary, best evidence-based dosing recommendations were proposed for dexmedetomidine, used as premedication prior to induction of anesthesia (intranasal dose) and for procedural sedation (intranasal and intravenous dose) in pediatric patients.
右美托咪定在全球范围内尚未被批准用于儿科临床治疗，但常被开给儿科患者作为麻醉诱导前的预用药或用于操作镇静。尽管有大量关于右美托咪定在这一脆弱患者群体中的药代动力学、疗效和安全性的文献，但在剂量方面普遍缺乏共识。在本项目中，我们旨在使用荷兰儿科处方集的标准化工作流程，为右美托咪定作为预用药和操作镇静制定最佳循证儿科剂量指南。
对儿科右美托咪定的现有文献进行了综述，以解决以下三个问题：（1）正确的剂量是多少？（2）疗效如何？（3）安全性如何？相关文献被汇编成一份风险效益分析文件。一组临床专家对分析和提出的剂量建议进行了批判性评估。
右美托咪定最常通过静脉或鼻内途径给药。清除率随年龄而变化，因此需要在婴儿中给予更高剂量，以达到与成人相似的暴露量。右美托咪定的使用可在父母分离时提供满意的镇静、足够的镇静效果和有利的恢复特征。安全性良好，与成人相当，存在剂量相关的血液动力学效应。
按照荷兰儿科处方集的结构化方法，为儿科患者的麻醉诱导前预用药（鼻内剂量）和操作镇静（鼻内和静脉内剂量）提出了基于最佳证据的右美托咪定剂量建议。
