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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右美托咪定用于儿科术前用药和程序性镇静的最佳循证给药建议：荷兰儿科处方集的风险收益分析结果

背景

右美托咪定目前在全球范围内用于儿科临床护理的标签外。然而，它经常被开给儿科患者作为麻醉诱导前的术前用药或用于程序镇静。有大量关于右美托咪定在这一易受伤害患者群体中的药代动力学、疗效和安全性的文献，但对剂量普遍缺乏共识。在这个项目中，我们旨在使用荷兰儿科处方集的标准化工作流程，为右美托咪定作为术前用药和程序镇静剂建立最佳循证儿科给药指南。

方法

回顾了有关右美托咪定在儿科中的现有文献，以解决以下三个问题：（1）正确的剂量是多少？(2) 对功效有什么了解？(3) 对安全有什么了解？相关文献被编入风险收益分析文件。一组临床专家严格评估了分析和建议的剂量建议。

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，因此需要在婴儿中使用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产生令人满意的镇静作用、充分的镇静作用和良好的恢复曲线。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

按照荷兰儿科处方集的结构化方法，对右美托咪定提出了最佳循证给药建议，在儿科患者中用作麻醉诱导前的术前用药（鼻内给药）和程序性镇静（鼻内和静脉给药）。