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Flumazenil Reversal of Oral Triazolam

NCT ID: NCT00695630

Last Updated: 2008-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Dental Anxiety

Keywords

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conscious sedation dental anxiety/drug therapy behavior/drug effects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Flumazenil 2mL

Group Type EXPERIMENTAL

Flumazenil

Intervention Type DRUG

2 mL, 0.2 mg SM

2

Saline, 2mL SM

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2 mL sterile saline SM

Interventions

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Flumazenil

2 mL, 0.2 mg SM

Intervention Type DRUG

Placebo

2 mL sterile saline SM

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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University of Washington

Principal Investigators

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Peter M Milgrom, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Dental Fears Research Clinic

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16415697 (View on PubMed)

Other Identifiers

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U54DE014254

Identifier Type: NIH

Identifier Source: secondary_id

View Link

T32007132

Identifier Type: -

Identifier Source: secondary_id

30779

Identifier Type: -

Identifier Source: org_study_id