| Project/Area Number |
03670985
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| Research Category |
Grant-in-Aid for General Scientific Research (C)
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| Allocation Type | Single-year Grants |
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| Research Field |
小児・社会系歯学
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| Research Institution | Aichi Gakuin University |
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Principal Investigator |
FUKUTA Osamu Aichi Gakuin University, Dentistry, Assistant Professor, 歯学部, 講師 (60090148)
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| Co-Investigator(Kenkyū-buntansha) |
YANASE Hiroshi Aichi Gakuin University, Dentistry, Instructor, 歯学部, 助手 (10211616)
田中 泰司 愛知学院大学, 歯学部, 助手 (90231414)
鈴木 善子 愛知学院大学, 歯学部, 講師 (70201580)
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| Project Period (FY) |
1991 – 1993
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| Project Status |
Completed (Fiscal Year 1993)
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| Budget Amount *help |
¥2,100,000 (Direct Cost: ¥2,100,000)
Fiscal Year 1993: ¥400,000 (Direct Cost: ¥400,000)
Fiscal Year 1992: ¥400,000 (Direct Cost: ¥400,000)
Fiscal Year 1991: ¥1,300,000 (Direct Cost: ¥1,300,000)
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| Keywords | Intranasal / Midazolam / Plasma concentration / Sedation / Sedative effect / Recovery time / Adverse effects / Dental treatment |
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| Research Abstract |
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.
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