Clinical trial NCT03360123: Comparison of Triazolam and Midazolam for Anxiolysis During Dental Treatment in the Pediatric Patient
Official title: Oral Anxiolysis for the Older Pediatric Patient-Which Medication is Preferred?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2017-12-02
Enrollment: 4
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Parent Survey
timeFrame: 10 minutes
measure: Behavior Assessment during dental treatment
timeFrame: 60-90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Whitney Eichholz, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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. doi: 10.1016/0030-4220(93)90086-j.
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. doi: 10.1177/00220345990780060201.
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. doi: 10.1016/S0099-2399(97)80272-5.
citation: 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.