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

NCT03360123 | Completed

• 1 other identifier: PRO17080173
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Anxiety

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Midazolam Hydrochloride 2Mg/mL Syrup

ACTIVE COMPARATOR

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

Triazolam 0.125 MG

ACTIVE COMPARATOR

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

Interventions

Midazolam Hydrochloride 2Mg/mL Syrup DRUG

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

Midazolam Hydrochloride 2Mg/mL Syrup

Triazolam 0.125 MG DRUG

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

Triazolam 0.125 MG

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Weigh 40 kilograms or more.
• /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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Publications (6)

• 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.

  PMID: 8227774 BACKGROUND

• 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.

  PMID: 10029963 BACKGROUND

• 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.

  PMID: 8426714 BACKGROUND

• 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.

  PMID: 10371242 BACKGROUND

• 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.

  PMID: 9594761 BACKGROUND

• 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.

  PMID: 16637480 BACKGROUND

MeSH Terms

Interventions

Midazolam; Triazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Whitney Eichholz, DDS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Dental Resident

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 2, 2017
• Study Start: January 26, 2018
• Primary Completion: April 11, 2018
• Study Completion: April 11, 2018
• Last Updated: June 19, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)