Does Preventive Analgesia Improve the Outcome of Demerol-Vistaril Procedural Sedations in Pediatric Dentistry?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Improved Sedation Effectiveness Based on Numerical Value for Effectiveness as Noted in Description
研究概览
简要总结
All healthcare providers strive continually to improve the outcome of their treatment approaches. The investigators hypothesize that preventive analgesics administered before a child is sedated with a Demerol-Vistaril regimen will improve the outcome of a sedation.
详细描述
To increase outcomes for patients receiving dental sedation by providing significant evidence that the new regimen improves the quality of sedation and results in an improved post sedation ability to eat, drink, resume normal activities and require less additional pain medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •We intend to enroll 300 children between the ages of 2 - 8 years of all ethnicities for this prospective, placebo controlled, randomized, and double-blind trial. All children that fulfill our general selection criteria for this sedation regimen will be eligible for this study.
排除标准
- •Children who do not meet our general selection criteria for this sedation regimen will be ineligible for this study.
研究组 & 干预措施
oral placebo
an Ibuprofen and Acetaminophen Placebo will be added to a Demerol-Vistaril regimen
干预措施: oral placebo (Drug)
Oral Analgesics
5 mg/kg ibuprofen + 15 mg/kg acetaminophen will be added to a Demerol-Vistaril regimen
干预措施: Oral Analgesics (Drug)
结局指标
主要结局
Improved Sedation Effectiveness Based on Numerical Value for Effectiveness as Noted in Description
时间窗: 60 minutes treatment started
A Sedation effectiveness evaluation criteria chart will be utilized to determine a numerical value for the effectiveness as follows: 1 = Effective/Excellent; 2 = Partially effective/good; 3 = Ineffective/fair; 4 = Aborted/Poor
次要结局
- Difference in Heart Rate as Measured by Numerical Delta Value(From state of treatment (time 0) 60 minutes)