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口服右美托咪定与氯胺酮镇痛镇静效果的比较评估:一项三盲随机研究。

A comparative evaluation of analgo-sedative effects of oral dexmedetomidine and ketamine: a triple-blind, randomized study.

作者信息

Singh Charanjeet, Pandey Ramesh K, Saksena Anil K, Chandra Girish

机构信息

Department of Pediatric and Preventive Dentistry, King George's Medical University, Lucknow, India.

出版信息

Paediatr Anaesth. 2014 Dec;24(12):1252-9. doi: 10.1111/pan.12493. Epub 2014 Jul 25.

Abstract

BACKGROUND

Use of sedative agents for difficult to manage children during dental procedures has been indicated for years, but neither the agent nor the route has been found to be ideal.

OBJECTIVES

The aim of the study was to evaluate and compare the efficacy and safety of oral dexmedetomidine (D) and ketamine (K) in producing moderate sedation among uncooperative pediatric dental patients.

METHODS

This prospective, triple-blind, randomized comparative study included 112 ASA grade I children of both sexes aged 3-10 years, who satisfied all the inclusion criteria. They were randomly divided into four groups and ketamine 8 mg·kg(-1) (K) or dexmedetomidine 3 μg·kg(-1) (D1), 4 μg·kg(-1) (D2) and 5 μg·kg(-1) (D3) were given orally. Similar dental procedures were performed in these patients, and effects of these drugs were assessed in terms of changes in vital signs, onset and duration of sedation, analgesia, and amnesia. Secondary outcomes such as level of sedation, behavior, adverse effects, and overall success were also measured.

RESULTS

The onset of sedation was significantly rapid with K and D3 as compared to D1 and D2. Recovery from sedation was fastest in group D1. Intra- and postoperative analgesia and anterograde amnesia were highest with K and least with D1, while D3 produced analgesia comparable to K. In K treated group, vomiting was observed in five patients and two patients exhibited emergence phenomenon. Overall, highest success rate was observed in D3 group.

CONCLUSIONS

Given by oral route, the novel sedative dexmedetomidine provides dose-dependent effective analgo-sedation, comparable to ketamine, with less adverse effects.

摘要

背景

多年来一直表明在牙科手术期间使用镇静剂来处理难以管理的儿童,但尚未发现该药物及其给药途径是理想的。

目的

本研究的目的是评估和比较口服右美托咪定(D)和氯胺酮(K)在不合作的儿科牙科患者中产生中度镇静的疗效和安全性。

方法

这项前瞻性、三盲、随机对照研究纳入了112名年龄在3至10岁之间、符合所有纳入标准的ASA I级儿童。他们被随机分为四组,分别口服8mg·kg⁻¹氯胺酮(K)或3μg·kg⁻¹(D1)、4μg·kg⁻¹(D2)和5μg·kg⁻¹(D3)右美托咪定。对这些患者进行了类似的牙科手术,并根据生命体征的变化、镇静、镇痛和遗忘的起效时间和持续时间评估了这些药物的效果。还测量了次要结果,如镇静水平、行为、不良反应和总体成功率。

结果

与D1和D2相比,K和D3的镇静起效明显更快。D1组的镇静恢复最快。K组的术中及术后镇痛和顺行性遗忘最高,D1组最低,而D3产生的镇痛效果与K相当。在K治疗组中,观察到5名患者呕吐,2名患者出现苏醒现象。总体而言,D3组的成功率最高。

结论

口服新型镇静剂右美托咪定可提供与氯胺酮相当的剂量依赖性有效镇痛镇静作用,且不良反应较少。

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