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临床试验/NCT04500158
NCT04500158已完成3 期

The Effect of Local Anesthesia When Used in Dental Restorative Cases Under General Anesthesia on Control of Intraoperative Physiologic Parameters and Post Operative Comfort

Virginia Commonwealth University1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2020年11月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
59
试验地点
1
主要终点
Post Operative Pain

研究概览

简要总结

The purpose of this study is to compare patient responses during and after surgery when local anesthetic is used for dental treatment under general anesthesia (GA) and when it is not used.

详细描述

Local anesthesia is a widely used tool to ensure patient safety and comfort in the dental office. This is usually accomplished by administering a shot of numbing medicine (local anesthesia) in different parts of the mouth. Local anesthesia is an important tool used for care in the dental office however despite its standardized use in dental clinics use of local anesthetic is not standardized for use in dental cases under GA. In the literature there is some evidence suggesting that it has some marginal benefit for pain control short term post operatively and control of vital signs during surgery. Some evidence also suggests that due to its use there can be increase in post-operative lip chewing and cheek biting due to the numb sensation. Additionally, it has been seen that due to the numb sensation that children can be more irritable during when waking up after surgery.

The study section will have 60 participants of which one half will receive local anesthesia for restorative dental care under GA and the other half will receive conventional no anesthesia for restorative dental treatment under GA, based on random assignment (like the flip of a coin). There is an equal chance of being assigned to either group prior to the consented treatment. Before the surgery, a nurse will access the child's overall pain and comfort. The study team (faculty, anesthesiologist, and resident) will record the blood pressure, heart rate, and breathing duration throughout the procedure. After the child has completed the surgery a nurse will again access the child's overall pain and comfort. Lastly, parents will be contacted that evening of surgery by a member of the study team to check up on the child and will be asked some questions to access the child's comfort at home.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
— 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients undergoing GA for dental restorative work at Virginia Commonwealth University Children's Hospital of Richmond Pavilion and Brook Road Centers

排除标准

  • Children with any sensory or behavioral issues
  • Patients requiring extractions or surgical procedures

研究组 & 干预措施

Local anesthesia

Experimental

Participants will receive local anesthesia in addition to the standard care general anesthesia

干预措施: Lidocaine (Drug)

结局指标

主要结局

Post Operative Pain

时间窗: in the evening of the day of surgery, up to 10 hours

The Parent's Postoperative Pain Measure ( abbreviated: PPPM) Scale consists of 15 questions with scores ranging from 0 to 15, with one point assigned to each question answered with a "Yes" and therefore higher scores indicating worse postoperative pain. A score of 6 or greater is considered clinically significant pain which was tallied for the primary outcome measure (i..e number of participants experiencing clinically significant postoperative pain).

次要结局

  • Number of Teeth Treated(start of procedure to end of procedure, the intraoperative time frme)
  • Procedure Time(start of procedure to end of procedure, minutes)
  • PACU Time(time from after procedure to through time in the post-anesthesia care unit in minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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