Effectiveness of Computerized Local Anesthesia in Reducing Local Anesthesia in Reducing Child Pain During Injection (RCT)
Effectiveness of Computerized Local Anesthesia in Reducing Local Anesthesia in Reducing Child Pain During Injection (Randomized Clinical Trial)
研究概览
地位
详细说明
: the aim of this study is to evaluate star pen computerized Local Anaesthesia in reducing child pain during injection, and its impact on child behavior during extraction of primary molars.
Materials and Methods: The research will be conducted in the form of a double-blind randomized controlled clinical trial with a parallel design. A total of 40 healthy children aged 4-6 years will be selected from the Pediatric Dentistry Department, Faculty of Dentistry, Pharos University in Alexandria, Egypt. Cooperative Children with Frankl behavioral rating scale scores of 3 or 4 will be selected. Each child chosen will have at least one maxillary or mandibular primary molar that requires extraction. The guardian's written informed consent will be obtained. Participants will be assigned into two groups of 20 children each based on the dental arch where the extraction will be performed: Group I (mandibular group); and Group II (maxillary group). Each group will be further subdivided into two subgroups: test group using the star pen computerized local anesthesia, and control group using the conventional method; IANB in the mandible, and infiltration local anesthesia in the maxilla according to the method of delivery of local anaesthesia. In the present study, pain during injection will be assessed by three methods: physiologically using the heart rate, objectively using Sound, Eye, Motor (SEM) scale, and subjectively using a modified face scale from the Maunuksela scale. In each child extraction of one primary molar will be performed according to the AAPD and child behavior will be assessed using Frankl Rating Scale.
Results: To obtain the study's results and conclusions, data will be collected, tabulated, and statistically analysed using SPSS version 26.0, with a significance level set at p < 0.05.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Alexandria、埃及
- Pharos University in Alexandria
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参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
Inclusion Criteria:
- Completion of the written informed consent form by parents/guardian.
- Children aged between 4 and 6 years.
- Medically fit patients classified as (ASA I).
- Cooperative children with a Frankl Behaviour Rating Scale of 3 or 4.
- Patients whom their primary molars are indicated for extraction, according to criteria of extraction of (AAPD).
Exclusion Criteria:
- Children with a history of allergy to local anaesthetic agents.
- Children who receive any analgesic drugs at least 24 h before treatment.
- Any inflammation or lesion in the injection site.
- Patients who have previous bad experience of dentistry to eliminate the possible impact of the child's previous painful or stressful experiences.
- Child coming for emergency treatment of pain.
- Teeth with ankylosed roots.
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Mandibular (IANB)
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CCLADS
infiltration or inferior alveolar local anesthesia
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实验性的:Maxillary Infiltration
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CCLADS
infiltration or inferior alveolar local anesthesia
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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heart rate
大体时间:The pulse oximeter will be placed on the patient's index finger to measure the the baseline heart rate (before giving the local anesthesia by 2 minutes), another measurement will be recorded during local anesthesia administration, and during extraction.
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measuring heart rate by pulse oximeter
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The pulse oximeter will be placed on the patient's index finger to measure the the baseline heart rate (before giving the local anesthesia by 2 minutes), another measurement will be recorded during local anesthesia administration, and during extraction.
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Sound, Eye, Motor (SEM) Scale
大体时间:will used as an objective method for pain assessment during anesthesia at end of injections immediately, after extraction immediately.
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objective method for pain assessment during LA administration scores from 1-->4 score 1=comfort(low score) score 4=severe discomfort (high score)
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will used as an objective method for pain assessment during anesthesia at end of injections immediately, after extraction immediately.
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 460 - 6/01/2026
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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