Flumazenil Reversal of Oral Triazolam
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Dental Anxiety |
Drug: Flumazenil Drug: Placebo |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Flumazenil Rescue Strategy |
- Observer Assessment of Alertness/Sedation [ Time Frame: 360 minutes ] [ Designated as safety issue: Yes ]
- BIS [ Time Frame: 360 minutes ] [ Designated as safety issue: Yes ]
| Enrollment: | 14 |
| Study Start Date: | September 2006 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Flumazenil 2mL
|
Drug: Flumazenil
2 mL, 0.2 mg SM
|
|
Placebo Comparator: 2
Saline, 2mL SM
|
Drug: Placebo
2 mL sterile saline SM
|
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- ASA I
Exclusion Criteria:
- Use of benzodiazepines, anxiolytics or any other medications that would interact with either triazolam's or flumazenil's metabolism or clinical effect (including herbals) within four weeks of the study
- Body mass index (BMI) no less than 15 kg/m2 and no greater than 30 kg/m2
- Pregnancy or not currently using pharmacologic methods of birth control
- Allergy or sensitivity to benzodiazepines
- History of a seizure disorder; AND
- Chronic tobacco use.
Contacts and Locations| United States, Washington | |
| Dental Fears Research Clinic | |
| Seattle, Washington, United States, 98195 | |
| Principal Investigator: | Peter M Milgrom, DDS | University of Washington |
More Information
Publications:
| Responsible Party: | Peter Milgrom/Professor of Dental Public Health Sciences, University of Washington |
| ClinicalTrials.gov Identifier: | NCT00695630 History of Changes |
| Other Study ID Numbers: | 30779, U54DE14254, T32007132 |
| Study First Received: | June 9, 2008 |
| Last Updated: | June 11, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Washington:
|
conscious sedation dental anxiety/drug therapy behavior/drug effects |
Additional relevant MeSH terms:
|
Anxiety Disorders Mental Disorders Flumazenil GABA Modulators GABA Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antidotes Protective Agents |
ClinicalTrials.gov processed this record on May 23, 2013