Oral Anxiolysis for the Older Pediatric Patient-Which Medication is Preferred?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Parent Survey
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Weigh 40 kilograms or more.
- •2/4 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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Midazolam Hydrochloride 2Mg/mL Syrup (Drug)
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.
干预措施: Triazolam 0.125 MG (Drug)
结局指标
主要结局
Parent Survey
时间窗: 10 minutes
Parents will complete a 4 questions post-treatment survey after the 2nd dental appointment.
Behavior Assessment during dental treatment
时间窗: 60-90 minutes
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.
次要结局
未报告次要终点
研究者
Whitney Eichholz
Pediatric Dental Resident
University of Pittsburgh