Flumazenil Reversal of Oral Triazolam

Overview

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).

Full Title of Study: “Flumazenil Rescue Strategy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2007

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Observer Assessment of Alertness/Sedation
    • Time Frame: 360 minutes

Secondary Measures

  • BIS
    • Time Frame: 360 minutes

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Washington
  • Collaborator
    • National Institutes of Health (NIH)
  • Provider of Information About this Clinical Study
    • Peter Milgrom/Professor of Dental Public Health Sciences, University of Washington
  • Overall Official(s)
    • Peter M Milgrom, DDS, Principal Investigator, University of Washington

References

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. doi: 10.1097/01.jcp.0000186742.07148.da.

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