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

Dental Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03360123
• Other study ID #: PRO17080173
• Status: Completed
• Phase: N/A
• Start date: January 26, 2018
• Est. completion date: April 11, 2018

Study information

• Verified date: June 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: April 11, 2018
• Est. primary completion date: April 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Anxiety

Intervention

Drug:
• Midazolam Hydrochloride 2Mg/mL Syrup
Midazolam HCl Syrup 0.5mg/kg (Max: 15mg) taken 10-15 minutes prior to dental treatment.
• Triazolam 0.125 MG
Triazolam: 0.125mg tablet taken 30 minutes prior to dental treatment.

Locations

Country	Name	City	State
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (6)

Berthold CW, Schneider A, Dionne RA. Using triazolam to reduce dental anxiety. J Am Dent Assoc. 1993 Nov;124(11):58-64. Review. — View Citation

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. — View Citation

Dionne RA, Yagiela JA, Coté 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parent Survey	Parents will complete a 4 questions post-treatment survey after the 2nd dental appointment.	10 minutes
Primary	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