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A study of intranasal sedation on dental treatment

鼻内镇静在牙科治疗中的研究

基本信息

批准号：
03670985
负责人：
FUKUTA Osamu
金额：
$ 1.34万
依托单位：
Aichi Gakuin University
依托单位国家：
日本
项目类别：
Grant-in-Aid for General Scientific Research (C)
财政年份：
1991
资助国家：
日本
起止时间：
1991 至 1993
项目状态：
已结题

来源：
https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-03670985/
关键词：
Intranasal Midazolam Plasma concentration Sedation Sedative effect Recovery time Adverse effects Dental treatment

项目摘要

The purpose of this study was to investigate of safety and sedative effect of intranasal sedation using midazolam and to determine the most appropriate concentration for the drug when administered by this route. The doses of intranasal midazolam were 0.2mg/kg or 0.3mg/kg.In pilot-study for healthy adults volunteers, the initial sedative effect appeared within 5 - 10 minutes and approximate maximal sedative effect was attend at 25 minutes in both groups. There were no significant difference between both groups on sedative effect. The highest average plasma concentration of midazolam in 0.2 mg/kg group was 157.0 ng/ml at 20 minutes, that in 0.3 mg/kg group was 257.7 ng/ml at 20 minutes. In both groups, there were no severe changes in blood pressure and heart rate in any phases. But there were light respiration depression in both groups. And respiration depression of 0.3 mg/kg group is more sever and frequent than that of 0.2 mg/kg group.In clinical study for mental disable patients, the success rates during dental treatment were 66.7%-100% in the 0.2 mg/kg and 83.3%-100% in the 0.3 mg/kg group. There were no significant difference in the success rate of any items in this study between two groups. The average recovery time of 0.2 mg/kg group was 129.3 minutes and that of the 0.3 mg/kg group was 131.8 minutes. The higher dose group exhibited slightly more frequent and significant adverse effects than the lower dose group.We recommend using the lower dose of 0.2 mg/kg intranasal midazolam for dental treatment. This techniques may be considered convenient and effective for dental treatment of uncooperative mentally handicapped patients.

本研究的目的是研究咪达唑仑鼻内镇静的安全性和镇静作用，并确定通过该途径给药时药物的最合适浓度。咪达唑仑鼻腔给药剂量为0.2mg/kg或0.3mg/kg，在健康成年志愿者的初步研究中，两组均在5 ~ 10分钟内起效，25分钟时达到最大镇静作用。两组镇静效果无显著性差异。咪达唑仑0.2mg/kg组20 min时平均血药浓度最高为157.0ng/ml，0.3mg/kg组20 min时平均血药浓度最高为257.7ng/ml。在两组中，血压和心率在任何阶段都没有严重变化。但两组均有轻度呼吸抑制。0.3mg/kg组呼吸抑制较0.2mg/kg组严重、频繁，在精神残疾患者的临床研究中，0.2mg/kg组治疗成功率为66.7%~ 100%，0.3mg/kg组为83.3%~ 100%。两组在本研究中的任何项目的成功率均无显著差异。0.2 mg/kg组的平均恢复时间为129.3 min，0.3 mg/kg组的平均恢复时间为131.8 min。高剂量组的不良反应发生率略高于低剂量组，我们建议使用0.2 mg/kg的低剂量咪达唑仑鼻内给药。这种技术可以被认为是方便和有效的牙科治疗不合作的弱智患者。