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临床试验/NCT01883232
NCT01883232撤回不适用

The Efficacy of Analgesic Buffering With Sodium Bicarbonate for the Pediatric Dental Patient

University of Colorado, Denver2 个研究点 分布在 1 个国家开始时间: 2013年8月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Time it takes for buffered injection to take effect measured in minutes.

研究概览

简要总结

As a dentist, administering anesthetic to patients, especially children, proves to be one of the most difficult parts of a procedure. Pain is one of the most common symptom in dentistry, and a serious concern for the dentist. The pain of the local anesthetic injection has several causes. Of the many reasons for pain at the site of injection, the acidity of the solution is thought to be most important. This study will be measuring the effects of adding sodium bicarbonate (buffer) to local anesthetic during dental procedures. This is commonly used in medical applications but is not widely used in the dental setting. Using this biochemistry and human physiology, one can predict when buffering the lidocaine injection, a quicker response in analgesia and a decrease in pain during administration. I will be measuring the effect using several measuring devices to gauge if buffering the local anesthetic will benefit the pediatric dental patient by reducing the time it takes for the analgesic effect as well as decreasing the pain during administration. Along with time, I will be using the Wong-Baker Scale to assess the pain. This scale is standard protocol for assessing pain in the pediatric population. The pediatric dental population has aversions to dental procedures because of the associated pain produced from most procedures. If limiting the time it takes for the analgesic to take effect and decrease the pain altogether, the pediatric patient will be less likely to skip treatment therefore, increase dental health.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Current patients of Children's Hospital Colorado Dental Clinic
  • Existence of carious primary molars necessitating administration of an anesthetic agent
  • No history of post traumatic stress disorder or specific phobia related to a dental setting
  • No allergic reaction to lidocaine
  • Patient's between the ages of 5 to 12.

排除标准

  • Allergies to local anesthetics or sulfites
  • History of significant medical conditions
  • Taking any medications that may affect anesthetic assessment
  • Active sites of pathology in areas if injection
  • Outside the age range of 5 -12.

结局指标

主要结局

Time it takes for buffered injection to take effect measured in minutes.

时间窗: 5 minutes

minutes for the analgesic effect to take place.

Change in pain rating using the Wong-Baker scale

时间窗: During injection (about 5 minutes)

By buffering the lidocaine/epinephrine injection, one should see a decrease in in pain during the administration of the anesthetic.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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