Flumazenil Reversal of Oral Triazolam

Phase 1

Completed

• Conditions: Dental Anxiety
• Interventions: Drug: Placebo; Drug: Flumazenil

• Registration Number: NCT00695630
• Lead Sponsor: University of Washington

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2008-06
• Study First Submitted: 2008-06-09
• Study First Submitted QC: 2008-06-11
• Last Update Submitted: 2008-06-11
• Study First Posted: 2008-06-12
• Last Update Posted: 2008-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Saline, 2mL SM
1	Flumazenil	Flumazenil 2mL

Primary Outcome Measures

Name	Time	Method
Observer Assessment of Alertness/Sedation	360 minutes

Secondary Outcome Measures

Name	Time	Method
BIS	360 minutes

Trial Locations

Locations (1)

Dental Fears Research Clinic; 🇺🇸 Seattle, Washington, United States