Flumazenil Reversal of Oral Triazolam

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT00695630
• Collaborator: National Institutes of Health (NIH) (NIH)
• Enrollment: 14
• Location: 1
• Arms: 2
• Duration (Months): 15
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Dental Anxiety	Drug: Flumazenil; Drug: Placebo	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Flumazenil Rescue Strategy
• Study Start Date: Sep 1, 2006
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Flumazenil 2mL	Drug: Flumazenil; 2 mL, 0.2 mg SM
Placebo Comparator: 2 Saline, 2mL SM	Drug: Placebo; 2 mL sterile saline SM

Outcome Measures

Primary Outcome Measures

1. Observer Assessment of Alertness/Sedation [360 minutes]

Secondary Outcome Measures

1. BIS [360 minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dental Fears Research Clinic	Seattle	Washington	United States	98195

Sponsors and Collaborators

• University of Washington
• National Institutes of Health (NIH)

Investigators

• Principal Investigator: Peter M Milgrom, DDS, University of Washington

Study Documents (Full-Text)

None provided.

More Information

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.

• ClinicalTrials.gov Identifier: NCT00695630
• Other Study ID Numbers: 30779; U54DE014254; T32007132
• First Posted: Jun 12, 2008
• Last Update Posted: Jun 12, 2008
• Last Verified: Jun 1, 2008

• Keywords provided by , ,: conscious sedation; dental anxiety/drug therapy; behavior/drug effects
• Additional relevant MeSH terms: Flumazenil

Study Results

No Results Posted as of Jun 12, 2008