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

Not Applicable

Completed

• Conditions: Dental Anxiety
• Interventions: Drug: Midazolam Hydrochloride 2Mg/mL Syrup; Drug: Triazolam 0.125 MG

• Registration Number: NCT03360123
• Lead Sponsor: University of Pittsburgh

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 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.

Study Timeline

• Study First Submitted: 2017-11-27
• Study First Submitted QC: 2017-11-27
• Study First Posted: 2017-12-02
• Study Start: 2018-01-26
• Primary Completion: 2018-04-11
• Study Completion: 2018-04-11
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-16
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Midazolam Hydrochloride 2Mg/mL Syrup	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.
Triazolam 0.125 MG	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.

Primary Outcome Measures

Name	Time	Method
Parent Survey	10 minutes	Parents will complete a 4 questions post-treatment survey after the 2nd dental appointment.
Behavior Assessment during dental treatment	60-90 minutes	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.

Trial Locations

Locations (1)

Children's Hospital of Pittsburgh of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States