Effectiveness of Vibratory Versus Cold Stimuli on Pain Perception During Needle Insertion in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Pain perception during needle insertion in different anesthetic techniques Using SEM scale
研究概览
简要总结
Local anesthesia is an anxiety-provoking procedure. Pain control is important for effective behavior guidance, specially among pediatric patients.
This study aims to evaluate the effectiveness of Buzzy® as a topical anesthetic in pain perception through two ways: once using vibration mode without the cold pack and the other using the cold pack without vibration and comparing it to topical anesthetic gel during different anesthetic techniques Methods: A randomized controlled clinical trial involving 72 healthy cooperative patients aged 5-9 years. They will be allocated to receive local anesthesia either using the vibration mode of Buzzy Bee (test group) or the cold pack of Buzzy Bee (test group) or conventional topical anesthetic gel (control group). Pain response will be assessed using Visual Analog Scale (VAS) and SEM scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients indicated for simple restorative procedures.
- •Children with physical status ASA I, II.
- •Children with no learning disabilities
- •Positive or definitely positive behavior during preoperative assessments according to the Frankl Scale.
- •Patients whom parents will give consent to participate
排除标准
- •Patients allergic to local anesthesia or having a family history of allergy to local anesthesia.
- •Patients with acute oral or facial infection (swelling and/or cellulites)
- •Having active sites of pathosis in the area of injection that could affect anesthetic assessment.
- •Children with special health care needs.
研究组 & 干预措施
topical anesthesia
Topical anesthetic gels are applied prior to injection at the injection site to minimize pain upon insertion of the needle during local anesthesia
干预措施: topical anesthetic gel (Other)
vibration
Vibration using a vibrating devise (Buzzy) can help reduce the pain during local anesthesia injection. It is placed extra-orally before and during needle insertion
干预措施: Vibration (Other)
cold pack
Cold pack provided with the Buzzy device will be used without the vibration mode of the device. It is applied extra-orally before and during needle insertion.
干预措施: Cold pack (Other)
结局指标
主要结局
Pain perception during needle insertion in different anesthetic techniques Using SEM scale
时间窗: during the procedure (needle insertion)
Objective method of pain assessment using SEM (sound, eye and movement scale). It is a behavioral assessment tool to evaluate pain and distress responses in children during dental procedures. It uses scores from 0 till 3 according to increasing levels of distress.
次要结局
- Pain will be assessed after local anesthesia injection by means of Visual analogue scale.(immediately after the procedure (needle insertion))
研究者
Dina Sharaf
Lecturer of Pediatric Dentistry
Alexandria University