Flumazenil Reversal of Oral Triazolam

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).

• Drug: Flumazenil
  2 mL, 0.2 mg SM
• Drug: Placebo
  2 mL sterile saline SM

• Experimental: 1
  Flumazenil 2mL
  Intervention: Drug: Flumazenil
• Placebo Comparator: 2
  Saline, 2mL SM
  Intervention: Drug: Placebo

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.