Flumazenil Reversal of Oral Triazolam

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00695630
First received: June 9, 2008
Last updated: June 11, 2008
Last verified: June 2008
  Purpose

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 Intervention Phase
Dental Anxiety
Drug: Flumazenil
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Flumazenil Rescue Strategy

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Observer Assessment of Alertness/Sedation [ Time Frame: 360 minutes ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • BIS [ Time Frame: 360 minutes ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: September 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00695630

Locations
United States, Washington
Dental Fears Research Clinic
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Peter M Milgrom, DDS University of Washington
  More Information

Publications:
Responsible Party: Peter Milgrom/Professor of Dental Public Health Sciences, University of Washington
ClinicalTrials.gov Identifier: NCT00695630     History of Changes
Other Study ID Numbers: 30779, U54DE14254, T32007132
Study First Received: June 9, 2008
Last Updated: June 11, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Washington:
conscious sedation
dental anxiety/drug therapy
behavior/drug effects

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Flumazenil
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on July 23, 2014