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Completed

NCT Number: NCT03360123

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

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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Key information

Conditions

Dental Anxiety

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Midazolam Hydrochloride 2Mg/mL Syrup

Drug

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

Triazolam 0.125 MG

Drug

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

Primary outcomes

  1. Parent Survey

    Time frame: 10 minutes

    Parents will complete a 4 questions post-treatment survey after the 2nd dental appointment.

  2. Behavior Assessment during dental treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 2, 2017
Registry last updated
Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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