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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam Hydrochloride 2Mg/mL Syrup | Drug | Midazolam HCl Syrup 0.5mg/kg (Max: 15mg) taken 10-15 minutes prior to dental treatment. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Whitney Eichholz, DDS | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8227774 | Background | 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. | |
| 10029963 | 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. |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D014229 | Triazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Triazolam 0.125 MG | Drug | Triazolam: 0.125mg tablet taken 30 minutes prior to dental treatment. |
|
| 8426714 | 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. |
| 10371242 | 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. |
| 9594761 | 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. |
| 16637480 | 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. |
| D006571 | Heterocyclic Compounds |