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

Study Overview
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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.

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.

Official Title
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Oral Anxiolysis for the Older Pediatric Patient-Which Medication is Preferred?

Conditions
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Dental Anxiety

Intervention / Treatment
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* Drug: Midazolam Hydrochloride 2Mg/mL Syrup
* Drug: Triazolam 0.125 MG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Midazolam Hydrochloride 2Mg/mL Syrup<br>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. | Drug: Midazolam Hydrochloride 2Mg/mL Syrup<br>* Midazolam HCl Syrup 0.5mg/kg (Max: 15mg) taken 10-15 minutes prior to dental treatment.<br>|
| Active Comparator: Triazolam 0.125 MG<br>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. | Drug: Triazolam 0.125 MG<br>* Triazolam: 0.125mg tablet taken 30 minutes prior to dental treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent Survey | Parents will complete a 4 questions post-treatment survey after the 2nd dental appointment. | 10 minutes | 
| Behavior Assessment during dental treatment | A chart review to assess patient behavior during treatment & successful completion of treatment will be completed on secure Children's Hospital of Pittsburgh of UPMC computers and will identify the patient through a coding system that will provide no link to patient identifiers. Patient behavior will be assessed using the Frankl Behavioral Rating scale. The behavior assessment will occur during the pre-sedation period, dental treatment and recovery period, which in total will take approximately 60-90 minutes. Your child's level of cooperation, willingness to accept treatment and emotions will be documented. Successful completion of treatment is determined by whether or not the treatment plan for that appointment was completed. | 60-90 minutes |