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鼻内氯胺酮与鼻内右美托咪定作为小儿全身麻醉前用药的疗效和安全性的系统评价和荟萃分析。

Efficacy and safety of intranasal ketamine compared with intranasal dexmedetomidine as a premedication before general anesthesia in pediatric patients: a systematic review and meta-analysis of randomized controlled trials.

机构信息

Department of Anaesthesiology, All India Institute of Medical Sciences, Gorakhpur, Uttar Pradesh, India.

Department of Pharmacology, All India Institute of Medical Sciences, Gorakhpur, Gorakhpur, Uttar Pradesh, 273008, India.

出版信息

Can J Anaesth. 2022 Nov;69(11):1405-1418. doi: 10.1007/s12630-022-02305-1. Epub 2022 Aug 16.

Abstract

PURPOSE

To compare the efficacy and safety of intranasal ketamine with intranasal dexmedetomidine as a premedication in pediatric patients undergoing general anesthesia for elective surgery or other procedures.

SOURCE

We conducted a systematic literature search in PubMed, PubMed Central, Scopus, LILACS, Google Scholar, the Cochrane Database of Systematic Reviews, and trial registries for randomized controlled trials (RCTs) comparing intranasal ketamine with intranasal dexmedetomidine as preanesthetic medication in elective surgery or other procedures in pediatric patients. We used Review Manager software version 5.4.1 for statistical analysis and adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We assessed the methodological quality of the included studies with the RoB 2 risk of bias tool. All outcomes were pooled using the Mantle-Haenszel method and a random-effects model. The quality of evidence was assessed using the GRADE approach.

PRINCIPAL FINDINGS

Out of 2,445 full texts assessed, we included ten RCTs in the analysis. The efficacy outcomes did not fulfill the comparability criteria between intranasal ketamine and intranasal dexmedetomidine for sedation at parental separation (risk ratio [RR], 0.90; 95% confidence interval [CI], 0.79 to 1.04; I = 89%; GRADE evidence, low), mask acceptance (RR, 0.86; 95% CI, 0.66 to 1.13; I = 50%; GRADE evidence, low), and iv canulation (RR, 1.16; 95% CI, 0.79 to 1.69; I = 69%; GRADE evidence, very low). Intranasal ketamine-treated patients showed a higher incidence of nausea and vomiting (RR, 2.47; 95% CI, 1.24 to 4.91; I = 0; GRADE evidence, moderate). Significantly more bradycardia was observed in the intranasal dexmedetomidine group (RR, 0.16; 95% CI, 0.04 to 0.70; I = 40%; GRADE evidence, moderate) than in the ketamine group.

CONCLUSION

The low to very low-quality evidence in this systematic review and meta-analysis of RCTs neither confirmed nor refuted comparable premedication efficacy of intranasal ketamine and dexmedetomidine in terms of parental separation, mask acceptance, and iv cannulation in a pediatric population. Clinical decision-making is likely to be influenced by differences in gastrointestinal and cardiovascular safety profiles.

STUDY REGISTRATION

PROSPERO (CRD42021262516); registered 22 July 2021.

摘要

目的

比较鼻内给予氯胺酮与鼻内给予右美托咪定作为小儿患者全身麻醉下择期手术或其他手术的术前用药的疗效和安全性。

资料来源

我们在 PubMed、PubMed Central、Scopus、LILACS、Google Scholar、Cochrane 系统评价数据库和试验登记处进行了系统文献检索,以比较鼻内给予氯胺酮与鼻内给予右美托咪定作为小儿患者择期手术或其他手术的术前用药的随机对照试验 (RCT)。我们使用 Review Manager 软件版本 5.4.1 进行统计分析,并遵循系统评价和荟萃分析的 Preferred Reporting Items 指南。我们使用 RoB 2 偏倚风险工具评估纳入研究的方法学质量。所有结局均采用 Mantel-Haenszel 方法和随机效应模型进行汇总。使用 GRADE 方法评估证据质量。

主要发现

在评估的 2445 篇全文中,我们纳入了 10 项 RCT 进行分析。在父母分离时镇静方面,疗效结局不符合鼻内给予氯胺酮与鼻内给予右美托咪定的可比性标准(风险比 [RR],0.90;95%置信区间 [CI],0.79 至 1.04;I = 89%;GRADE 证据,低)、面罩接受度(RR,0.86;95% CI,0.66 至 1.13;I = 50%;GRADE 证据,低)和静脉穿刺(RR,1.16;95% CI,0.79 至 1.69;I = 69%;GRADE 证据,非常低)。接受鼻内氯胺酮治疗的患者恶心和呕吐的发生率更高(RR,2.47;95% CI,1.24 至 4.91;I = 0;GRADE 证据,中)。与氯胺酮组相比,右美托咪定组观察到更多的心动过缓(RR,0.16;95% CI,0.04 至 0.70;I = 40%;GRADE 证据,中)。

结论

这项 RCT 的系统评价和荟萃分析的低至非常低质量证据既没有证实也没有反驳鼻内给予氯胺酮与右美托咪定在小儿人群中父母分离、面罩接受度和静脉穿刺方面具有可比较的术前用药疗效。临床决策可能受到胃肠道和心血管安全性特征差异的影响。

研究注册

PROSPERO(CRD42021262516);2021 年 7 月 22 日注册。

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