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

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Anxiety
• Intervention / Treatment: Drug: Midazolam Hydrochloride 2Mg/mL Syrup; Drug: Triazolam 0.125 MG

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Children's Hospital of Pittsburgh of UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Whitney Eichholz, DDS, University of Pittsburgh

Publications and helpful links

General Publications

• Berthold CW, Schneider A, Dionne RA. Using triazolam to reduce dental anxiety. J Am Dent Assoc. 1993 Nov;124(11):58-64. doi: 10.14219/jada.archive.1993.0233.
• Coldwell SE, Awamura K, Milgrom P, Depner KS, Kaufman E, Preston KL, Karl HW. Side effects of triazolam in children. Pediatr Dent. 1999 Jan-Feb;21(1):18-25.
• Kaufman E, Hargreaves KM, Dionne RA. Comparison of oral triazolam and nitrous oxide with placebo and intravenous diazepam for outpatient premedication. Oral Surg Oral Med Oral Pathol. 1993 Feb;75(2):156-64. doi: 10.1016/0030-4220(93)90086-j.
• Raadal M, Coldwell SE, Kaakko T, Milgrom P, Weinstein P, Perkis V, Karl HW. A randomized clinical trial of triazolam in 3- to 5-year-olds. J Dent Res. 1999 Jun;78(6):1197-203. doi: 10.1177/00220345990780060201.
• Ehrich DG, Lundgren JP, Dionne RA, Nicoll BK, Hutter JW. Comparison of triazolam, diazepam, and placebo as outpatient oral premedication for endodontic patients. J Endod. 1997 Mar;23(3):181-4. doi: 10.1016/S0099-2399(97)80272-5.
• Dionne RA, Yagiela JA, Cote CJ, Donaldson M, Edwards M, Greenblatt DJ, Haas D, Malviya S, Milgrom P, Moore PA, Shampaine G, Silverman M, Williams RL, Wilson S. Balancing efficacy and safety in the use of oral sedation in dental outpatients. J Am Dent Assoc. 2006 Apr;137(4):502-13. doi: 10.14219/jada.archive.2006.0223.

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2018
• Primary Completion (Actual): April 11, 2018
• Study Completion (Actual): April 11, 2018

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (Actual): December 2, 2017

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 16, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Triazolam
• Other Study ID Numbers: PRO17080173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No