Flumazenil Reversal of Oral Triazolam

Dental Anxiety Clinical Trial

Official title:

Flumazenil Rescue Strategy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00695630
• Other study ID #: 30779
• Secondary ID: U54DE014254T3200
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 9, 2008
• Last updated: June 11, 2008
• Start date: September 2006
• Est. completion date: December 2007

Study information

• Verified date: June 2008
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Anxiety

Intervention

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

Locations

Country	Name	City	State
United States	Dental Fears Research Clinic	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Jackson DL, Milgrom P, Heacox GA, Kharasch ED. Pharmacokinetics and clinical effects of multidose sublingual triazolam in healthy volunteers. J Clin Psychopharmacol. 2006 Feb;26(1):4-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observer Assessment of Alertness/Sedation		360 minutes	Yes
Secondary	BIS		360 minutes	Yes