Effect of Buffered Anesthetic on Physiological Reactions During Dental Injection in Young Children Under Deep Sedation: A Prospective, Single Visit, Randomized, Double-Blind Split Mouth Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Diastolic Blood Pressure as Measured by Medical Record
研究概览
简要总结
The purpose of this research study is to compare responses in children during dental injections of local anesthetic (used for numbing), while children are under deep sedation (breathing on their own, often with a loss of consciousness). Two types of local anesthetic will be used--one will be buffered (by adding a salt solution to make it less acidic), while the other will be plain, without anything added. Previous studies have shown that the addition of the buffer solution can improve comfort during a dental injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Participant and Care provider is blinded as to which side is buffered and which is non-buffered
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children or children with mild controlled systemic illness
- •Treatment planned to receive restorative work on both sides of mouth (left vs right) under deep sedation, requiring local anesthetic administration
排除标准
- •Children present with any illness or symptoms that can alter pain perception such as pain in head and neck area due to TMJ disorders, arthritis, autoimmune diseases
- •Antibiotic premedication requirement
- •History of taking medications (NSAIDs, narcotics, sedatives, and antianxiety or antidepressant medications) that may affect anesthetic assessment
- •Has signs of dental pain, odontogenic abscess or facial cellulitis
- •Allergy to local anesthetics or sulfites
研究组 & 干预措施
Buffered Anesthetic Side/Non-buffered Anesthetic Side
Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic.
Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic.
干预措施: Non-buffered Anesthetic (Drug)
Buffered Anesthetic Side/Non-buffered Anesthetic Side
Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic.
Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic.
干预措施: Buffered Anesthetic (Drug)
Buffered Anesthetic Side/Non-buffered Anesthetic Side
Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic.
Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic.
干预措施: Onset (Device)
结局指标
主要结局
Change in Diastolic Blood Pressure as Measured by Medical Record
时间窗: Baseline, Up to 10 minutes
Change in Heart Rate as Measured by as Measured by Medical Record
时间窗: Baseline, Up to 10 minutes
Change in Systolic Blood Pressure as Measured by Medical Record
时间窗: Baseline, Up to 10 minutes
Change in CO2 Level as Measured by Medical Record
时间窗: Baseline, Up to 10 minutes
Pain Score as Measured by the Behavior Pain Scale
时间窗: Up to 10 minutes
The BPS score ranges from 2 to 8 points. The higher the score, the more potential pain an unconscious patient is experiencing during sedation procedures.
Change in Oxygen Saturation Level as Measured by Medical Record
时间窗: Baseline, Up to 10 minutes
次要结局
未报告次要终点