Effect of the DentalVibe Injections System on Pain During Local Anesthesia Injections in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Self Reported Pain Rating Using Wong-Baker FACES Scale
研究概览
简要总结
Title: Effect of the DentalVibe injection system on pain during local anesthesia injections in children.
Purpose: The purpose of this study is to compare self-reported pain scale measurements using the Wong-Baker FACES pain rating scale from an experimental group (local anesthesia injection with DentalVibe system) and a control group (traditional local anesthesia injection with DentalVibe system turned off) in children.
Eligibility: Children age 5-11 years old who require local anesthesia for bilateral dental treatment at University of Nebraska Medical Center (UNMC) pediatric dental clinic. Children must understand and speak English.
Interventions and evaluations: Each patient will have two separate restorative appointments where the DentalVibe will be used during local anesthetic injections. One appointment the DentalVibe will be turned on and one appointment the DentalVibe will be turned off. After each injection the child will be shown the Wong Baker FACES Pain Rating Scale and asked to pick a face associated with their level of hurt during the injection.
Follow-up: All children will be followed up with any necessary recommended dental treatment.
详细描述
Up to 50 children between the ages of 5-11 years will participate in this randomized, controlled, cross-over, split-mouth study. There will be no gender restrictions used in this study. Participants will be recruited from a continuous sample of patient seen at the UNMC pediatric dental clinic and will be selected based on their need for dental treatment. Each child will have 2 separate dental appointments.
Written consent will be obtained from parent or guardian prior to first restorative appointment. Verbal consent will be obtained prior to second restorative appointment.
Dr. Marshall will be the provider for every patient. The same dental assistant will be used for each appointment. All treatment will be completed in the same private quiet room. Both Dr. Marshall and the dental assistant will wear the same color scrubs and black lab jackets during all appointments.
One appointment patient will receive local anesthetic dental injection with the DentalVibe turned on and at one appointment the child will receive local anesthetic dental injection with the DentalVibe off. Used strictly as a check/lip retractor. The child will be randomly assigned via a random number generator to either the DentalVibe on or off during the initial appointment. During the DentalVibe turned on appointment, the DentalVibe will be introduced to each child to make him/her familiar with the vibration sensation.
All patients will receive 5 mins of O2, then nitrous oxide (N2O) will be titrated up to 50%N2O/50%O2. When appointment is complete the child will receive 5 mins of 100% O2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The person administering the FACES pain rating scale will be masked
入排标准
- 年龄范围
- 5 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between the ages of 5-11 who require dental treatment that requires bilateral local anesthesia on the maxilla or mandible. Subjects must understand and speak English.
排除标准
- •No children with presence of medically or developmentally compromising conditions (autism, cerebral palsy, moderate/severe asthma); history of chronic disease (seizure disorder, cardiac disorder, hematological disease, endocrine disorder, liver disease, renal disease). Non-English speakers will be excluded. Subject who require oral sedation or general anesthesia for treatment due to behavior or medical history will be excluded.
结局指标
主要结局
Self Reported Pain Rating Using Wong-Baker FACES Scale
时间窗: Immediately after local anesthetic delivery
The scale includes pictures of facial expressions with correlating numerical scale of 0-10. 0 being no hurt and 10 being the worst hurt.
次要结局
未报告次要终点