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| ID | Type | Description | Link |
|---|---|---|---|
| U54DE014254 | U.S. NIH Grant/Contract | View source | |
| T32007132 |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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An increase in the utilization of anesthesia and sedation medications by non-anesthesiologists, including dentists, has grown dramatically. This has been prompted, in part, by the need for pharmacological tools to address high levels of fear and anxiety about dental care among the US population and the evidence of oral health disparities among those who are fearful . Given the prevalence of dental fear in the general population and in the various populations with the greatest burden of oral diseases, effective sedation techniques are needed that are safe and effective in the hands of general dentists that make up the "front line" in the efforts to reduce oral health disparities. This study is to determine whether, when compared to a saline placebo, a single intraoral submucosal administration of the benzodiazepine antagonist flumazenil (0.2 mg) is capable of attenuating in 10 minutes or less the central nervous system (CNS) depression produced by a paradigm of stacked sublingual dosing of triazolam (3 doses of 0.25 mg over 90 minutes).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Flumazenil 2mL |
|
| 2 | Placebo Comparator | Saline, 2mL SM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flumazenil | Drug | 2 mL, 0.2 mg SM |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Observer Assessment of Alertness/Sedation | 360 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| BIS | 360 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter M Milgrom, DDS | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dental Fears Research Clinic | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16415697 | Background | Jackson DL, Milgrom P, Heacox GA, Kharasch ED. Pharmacokinetics and clinical effects of multidose sublingual triazolam in healthy volunteers. J Clin Psychopharmacol. 2006 Feb;26(1):4-8. doi: 10.1097/01.jcp.0000186742.07148.da. |
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| ID | Term |
|---|---|
| D005442 | Flumazenil |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Drug |
2 mL sterile saline SM |
|
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |