BACKGROUND 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. METHOD 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. RESULTS 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. CONCLUSION 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.

中文翻译：

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用于儿科术前用药和程序镇静的右美托咪定的最佳循证剂量建议：荷兰儿科处方集风险效益分析的结果。

背景 右美托咪定目前在全球范围内用于儿科临床护理的适应证外。然而，它经常被用作儿科患者麻醉诱导前的术前用药或程序镇静。关于右美托咪定在这一弱势患者群体中的药代动力学、疗效和安全性有大量文献，但在剂量方面普遍缺乏共识。在该项目中，我们的目标是利用荷兰儿科处方集的标准化工作流程，为右美托咪定作为术前用药和程序镇静建立最佳循证儿科剂量指南。方法 回顾儿科右美托咪定的现有文献，以解决以下三个问题：（1）正确的剂量是多少？(2) 关于功效，已知什么？(3) 安全方面的知识有哪些？相关文献整理成风险收益分析文件。临床专家团队对分析和提出的剂量建议进行了严格评估。结果 右美托咪定最常通过静脉内或鼻内途径给药。清除率取决于年龄，因此婴儿需要更高剂量才能达到与成人相似的暴露量。使用右美托咪定可在父母分离时实现令人满意的镇静、充分的镇静和良好的恢复情况。安全性良好，与成人相当，具有剂量相关的血流动力学效应。结论 根据荷兰儿科处方集的结构化方法，提出了右美托咪定的最佳循证剂量建议，用作儿科患者麻醉诱导前的术前用药（鼻内剂量）和程序镇静（鼻内和静脉剂量）。