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滴鼻与雾化鼻内给予氯胺酮用于不合作小儿牙科患者程序性镇静的比较评估:一项前瞻性交叉试验。

A comparative evaluation of drops versus atomized administration of intranasal ketamine for the procedural sedation of young uncooperative pediatric dental patients: a prospective crossover trial.

作者信息

Pandey R K, Bahetwar S K, Saksena A K, Chandra Girish

机构信息

Department of Pedodontics and Preventive Dentistry, Faculty of Dental Sciences, C.S.M. Medical University, Lucknow, Uttar Pradesh, India.

出版信息

J Clin Pediatr Dent. 2011 Fall;36(1):79-84. doi: 10.17796/jcpd.36.1.1774746504g28656.

DOI:10.17796/jcpd.36.1.1774746504g28656
PMID:22900449
Abstract

OBJECTIVE

The objective of this study was to compare and evaluate the efficacy and safety of drops and atomized administration of intranasal ketamine (INK) in terms of behavioral response for agent acceptance during administration and for agent efficacy and safety for the sedation of young uncooperative pediatric dental patients.

STUDY DESIGN

Thirty-four uncooperative ASA grade-1 children, requiring dental treatment were randomly assigned to receive INK as drops and atomized spray in one of the subsequent visit. This was a two stage cross-over trial and each child received INK by both modes of administration. The vital signs were monitored continuously during each visit.

RESULTS

A statistically significant difference in patients acceptance (P < 0.0001) was observed in the atomized administration when compared to drops administration for the procedural event of drug administration. Moreover there were also significant differences (P < 0.05) between onset of sedation and recovery time between two groups. All the vital signs were within normal physiological limits and there were no significant adverse effects in either group.

CONCLUSIONS

INK is safe and effective by either mode of intranasal (IN) drug administration for moderate sedation in facilitating dental care for anxious and uncooperative pediatric dental patients. Moreover, INK when administered with the mucosal atomization device, the acceptance of the drug was associated with less aversive reaction, rapid onset and recovery of sedation, as compared to the drop administration of the same agent.

摘要

目的

本研究的目的是比较和评估鼻内给予氯胺酮(INK)滴剂和雾化给药在给药过程中药物接受的行为反应以及对年轻不合作儿科牙科患者镇静的药物疗效和安全性方面的效果和安全性。

研究设计

34名需要牙科治疗的不合作ASA 1级儿童被随机分配在随后的一次就诊中接受INK滴剂和雾化喷雾给药。这是一项两阶段交叉试验,每个儿童都通过两种给药方式接受INK。每次就诊期间持续监测生命体征。

结果

在给药操作事件中,与滴剂给药相比,雾化给药时患者接受度有统计学显著差异(P < 0.0001)。此外,两组之间的镇静起效时间和恢复时间也有显著差异(P < 0.05)。所有生命体征均在正常生理范围内,两组均无明显不良反应。

结论

对于焦虑和不合作的儿科牙科患者,通过鼻内(IN)给药的任何一种方式给予INK进行中度镇静都是安全有效的,可促进牙科护理。此外,与相同药物的滴剂给药相比,当使用粘膜雾化装置给予INK时,药物的接受度与较少的厌恶反应、快速的镇静起效和恢复相关。

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