Effect of Pre-Warming of Local Anesthesia in Reducing Pain Perception During Injection in Children: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Heart rate (HR) monitoring
研究概览
简要总结
The aim of the current study was to evaluate the pain perception upon injection of pre-warmed dental anesthetic solution (at 370C and 400C) versus that at room temperature (Average 23 degrees) during Maxillary Infiltration and Mandibular Inferior Alveolar Nerve Block techniques in children
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy patients with ASA 1 or 2 Classification.
- •Patients with Frankl Behavior Classification 3-
- •Patients having at least one carious primary molar that requires dental treatment under the effect of local anesthesia.
- •Parents' willingness to participate through informed written consent.
排除标准
- •Patients with previous negative dental experience.
- •Patients complaining of cellulitis or infection spreading in the fascial spaces.
- •Patients who have received analgesics within the previous 12 hours before receiving the required dental treatment.
- •Patients with any Intellectual Impairment.
- •Patients with a history of allergy from any of the components of the dental anesthetic carpule.
结局指标
主要结局
Heart rate (HR) monitoring
时间窗: during local anesthesia administration
A pulse oximeter will be used to record and measure the patient's heart rate. A baseline reading will be obtained before the LA administration and another reading will be obtained directly after the injection is carried out. Heart rate ranging between 70-100 is considered normal.
Pain during injection using Face scale
时间窗: during local anesthesia administration
To assess pain subjectively during local anesthesia administration, a modified face scale. It consists of three schematic faces with different facial expressions for happy and sad faces representing: 1. Satisfaction 2. Indifference 3. Dissatisfaction Each patient was trained on using the scale by modelling and then requesting from every patient to think of the last time she/he went through a painful experience and to choose the facial expression that best relates his/her current experience of discomfort to the previous one
Pain during injection using Sound, Eye, Motor (SEM) Scale
时间窗: during local anesthesia administration
Sound, Eye, Motor (SEM) Scale was used as an objective mean to assess pain during local anesthesia administration. It comprises the following parameters: * Sound * Eye * Bodily movements The slightest changes in the sound, eye movement and bodily movement of the patient will be categorized as one of the following levels; comfortable, mild, moderate, and severe discomfort and hence given a grade of 1, 2, 3 or 4 respectively. The final SEM score will be calculated by adding the grades of the three parameters.
次要结局
未报告次要终点
研究者
Andrew Emad
Pediatric Dentist
Alexandria University