Flumazenil Reversal of Oral Triazolam
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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).
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
14 participants in 2 patient groups, including a placebo group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal