A study of intranasal sedation on dental treatment

本研究的目的是研究咪达唑仑鼻腔镇静的安全性和镇静效果，并确定该药的最佳给药浓度。咪达唑仑的鼻腔剂量为0.2 mg/kg或0.3 mg/kg。在健康成人志愿者的先导研究中，两组患者在5-10分钟内开始镇静，并在25分钟时达到接近最大的镇静效果。两组镇静效果差异无统计学意义。咪达唑仑0.2 mg/kg组20min最高血药浓度为157.0 ng/ml，0.3 mg/kg组20min最高血药浓度为257.7 ng/ml。在两组中，血压和心率在任何阶段都没有严重的变化。但两组均有轻度呼吸抑制。在智障患者的临床研究中，0.2 mg/kg组牙科治疗成功率为66.7%~100%，0.3 mg/kg组牙科治疗成功率为83.3%~100%。在这项研究中，两组在任何项目上的成功率都没有显著差异。0.2 mg/kg组平均恢复时间为129.3分钟，0.3 mg/kg组平均恢复时间为131.8分钟。高剂量组的不良反应发生率略高于低剂量组，建议使用0.2 mg/kg的低剂量咪达唑仑鼻腔给药。这种技术可以被认为是治疗不合作的智障患者的方便和有效的方法。

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.