Status:

COMPLETED

Comparison of Triazolam and Midazolam for Anxiolysis During Dental Treatment in the Pediatric Patient

Lead Sponsor:

University of Pittsburgh

Conditions:

Dental Anxiety

Eligibility:

All Genders

7-17 years

Phase:

NA

Brief Summary

This study will evaluate the perceptions of the effects of two anxiolytic medications commonly used during dental treatment in patients weighing 40 kilograms or more.

Detailed Description

Midazolam and nitrous oxide are commonly used in pediatric patients requiring anxiolysis during dental treatment. Triazolam and nitrous oxide are commonly used in adult patients requiring anxiolysis d...

Eligibility Criteria

Inclusion

  • Weigh 40 kilograms or more.
  • 2/4 or 3/4 Frankl Behavioral Rating at their evaluation appointment.
  • Dental treatment that requires two sedation appointments. Dental treatment that requires sedation includes: fillings, crowns, pulpotomies and/or extractions.
  • Between the ages of 7-17 years old.

Exclusion

  • Patients taking any of the following medications will be excluded from the study: Atripia, cimetidine, diltiazem, erythromycin, fluconazole, grapefruit juice, isoniazid, itraconazole, ketoconazole, nefazodone, rifampicin, ritonavir, fusidic acid, idelalisisb, methadone, olanzapine, thalidomide and/or troleandomycin.
  • Pregnant patients will be excluded.
  • Patients that have HIV-1 that is being treated with a protease inhibitor will be excluded.
  • Patients with a MTHFR mutation will be excluded.
  • Patients with acute narrow angle glaucoma will be excluded.
  • Patients that have had a previous adverse, paradoxical or allergic reaction to any benzodiazepines will be excluded from the study.
  • Patients unable to swallow medication in tablet form.
  • Patients that do not speak English as their primary language.

Key Trial Info

Start Date :

January 26 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 11 2018

Estimated Enrollment :

4 Patients enrolled

Trial Details

Trial ID

NCT03360123

Start Date

January 26 2018

End Date

April 11 2018

Last Update

June 19 2018

Active Locations (1)

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1

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States, 15224