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Evaluation of the safety of using propofol for paediatric procedural sedation: A systematic review and meta-analysis

机译:丙泊酚用于小儿手术镇静的安全性评估:系统评价和荟萃分析

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摘要

Propofol is one of the most widely used drugs for paediatric procedural sedation owing to its known advantages, but some concerns remain regarding respiratory and/or cardiac complications in patients receiving propofol. Although a considerable number of randomised controlled clinical trials (RCTs) have been conducted to compare it with other sedative agents or opioids for children undergoing various procedures, propofol is still being used off-label for this indication in many countries. We performed a systematic review and meta-analysis of those RCTs to provide an overall summation of evidence that can potentially be considered for further regulatory decisions, including reimbursement policies. We searched for RCTs in MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials from their inception to January 31, 2018. Our meta-analysis of 30 RCTs confirmed that propofol sedation had advantages in recovery time when compared with other drugs, without excessive concerns for cardiovascular or respiratory adverse events. Its safety profile regarding coughing, nausea or vomiting, and emergence delirium was also similar to that of other drugs. The overall evidence suggests that propofol sedation for paediatric procedures should be considered more positively in the context of regulatory decisions.
机译:丙泊酚由于其已知的优点而成为儿科手术镇静中使用最广泛的药物之一,但是对于接受丙泊酚的患者的呼吸系统和/或心脏并发症仍存在一些担忧。尽管已经进行了大量的随机对照临床试验(RCT)来将其与接受各种程序治疗的儿童的其他镇静剂或阿片类药物进行比较,但在许多国家,丙泊酚仍在标签外使用。我们对这些RCT进行了系统的审查和荟萃分析,以提供证据的整体汇总,可以为进一步的监管决策(包括补偿政策)考虑证据。从研究开始到2018年1月31日,我们在MEDLINE,Embase和Cochrane对照试验中心登记册中搜索了RCT。我们对30份RCT进行荟萃分析,证实丙泊酚镇静与其他药物相比在恢复时间上具有优势,而且没有过多关注心血管或呼吸系统不良事件。它在咳嗽,恶心,呕吐和emerge妄出没方面的安全性也与其他药物相似。总体证据表明,在监管决策的背景下,应更积极地考虑将丙泊酚镇静用于儿科手术。

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