Flumazenil Reversal of Oral Triazolam
Information source: University of Washington
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dental Anxiety
Intervention: Flumazenil (Drug); Placebo (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: University of Washington Official(s) and/or principal investigator(s):
Peter M Milgrom, DDS, Principal Investigator, Affiliation: University of Washington
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).
Clinical Details
Official title: Flumazenil Rescue Strategy
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
Primary outcome: Observer Assessment of Alertness/Sedation
Secondary outcome: BIS
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Dental Fears Research Clinic, Seattle, Washington 98195, United States
Additional Information
Related publications: 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.
Starting date: September 2006
Ending date: December 2007
Last updated: June 11, 2008
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