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Flumazenil Reversal of Oral Triazolam

Flumazenil Rescue Strategy

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00695630
Enrollment
14
Registered
2008-06-12
Start date
2006-09-30
Completion date
2007-12-31
Last updated
2008-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Anxiety

Keywords

conscious sedation, dental anxiety/drug therapy, behavior/drug effects

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).

Interventions

DRUGFlumazenil

2 mL, 0.2 mg SM

DRUGPlacebo

2 mL sterile saline SM

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
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.

Design outcomes

Primary

MeasureTime frame
Observer Assessment of Alertness/Sedation360 minutes

Secondary

MeasureTime frame
BIS360 minutes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026