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

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

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-26

Study Completion Date

2018-04-11

Brief Summary

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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.

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Detailed Description

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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 during dental treatment. The participants in this study are patients already scheduled for 2 sedation appointments to complete their dental treatment. The medications are both benzodiazepines that have similar risks, neither medication has greater adverse effects than the other. This study will evaluate the perceptions of the effects of the medications via a parent survey and chart review. The goal of the study is to determine which anxiolytic medication is perceived to provide a better sedation experience for older pediatric patients based on parent perception of the medication's effects and the patient's behavior during dental treatment.

Conditions

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Dental Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Midazolam Hydrochloride 2Mg/mL Syrup

The participants in this arm will receive midazolam+nitrous oxide at the 1st dental appointment.

Dosage: Midazolam: Midazolam HCl Syrup 0.5mg/kg (Max: 15mg) taken 10-15 minutes prior to dental treatment.

Group Type ACTIVE_COMPARATOR

Midazolam Hydrochloride 2Mg/mL Syrup

Intervention Type DRUG

Midazolam HCl Syrup 0.5mg/kg (Max: 15mg) taken 10-15 minutes prior to dental treatment.

Triazolam 0.125 MG

The participants in this arm will receive triazolam+nitrous oxide at the 1st dental appointment. Dosage: Triazolam: 0.125mg tablet taken 30 minutes prior to dental treatment.

Group Type ACTIVE_COMPARATOR

Triazolam 0.125 MG

Intervention Type DRUG

Triazolam: 0.125mg tablet taken 30 minutes prior to dental treatment.

Interventions

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Midazolam Hydrochloride 2Mg/mL Syrup

Midazolam HCl Syrup 0.5mg/kg (Max: 15mg) taken 10-15 minutes prior to dental treatment.

Intervention Type DRUG

Triazolam 0.125 MG

Triazolam: 0.125mg tablet taken 30 minutes prior to dental treatment.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. 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.
2. Pregnant patients will be excluded.
3. Patients that have HIV-1 that is being treated with a protease inhibitor will be excluded.
4. Patients with a MTHFR mutation will be excluded.
5. Patients with acute narrow angle glaucoma will be excluded.
6. Patients that have had a previous adverse, paradoxical or allergic reaction to any benzodiazepines will be excluded from the study.
7. Patients unable to swallow medication in tablet form.
8. Patients that do not speak English as their primary language.

Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes