Comparative evaluation of Transcutaneous Electrical Nerve Stimulation and Combination of External Cold and Vibration for pain perception during administration of Local Anesthesia in pediatric dental patients – An in vivo study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To evaluate and compare the pain perception during administration of local anesthesia using Transcutaneous Electrical Nerve Stimulation and combination of external cold and vibration in pediatric dental patients.
研究概览
简要总结
THE PURPOSE OF THIS STUDY IN- VIVO STUDY WILL BE TO EVALUATE AND COMPARE THE PAIN PERCEPTION DURING ADMINISTRATION OF LOCAL ANESTHESIA USING TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION AND COMBINATION OF EXTERNAL COLD AND VIBRATION IN PEDIATRIC DENTAL PATIENTS.
Ninety healthy, cooperative children of age group 5-10 years will be selected based on the inclusion and exclusion criteria. The selected children will be randomly divided into three groups:
GROUP I: Transcutaneous electrical nerve stimulation group
GROUP II: Combination of external cold and vibration group
GROUP III: Conventional syringe group
CLINICAL PROCEDURE
Before the commencement of the treatment, the procedure will be fully explained to the patient and patient’s parent in simple words, with the main criteria being administration of local anesthesia. Informed consent will be taken. The pain assessment will be done using Wong Baker’s faces pain rating scale before the administration of anesthesia.
Group I (Transcutaneous Electrical Nerve Stimulation Group): After the child will be seated on the dental chair, he/she will be first made familiar to the device by explaining how it works in simple words and then the electrode pads will be applied extraorally above the area where local anesthetic is to delievered. Local anesthetic will be delivered using conventional 2 mL syringe in the area adjacent to the tooth requiring treatment.
Group II (Combination of external cold and vibration Group): Buzzy**® (Pain Care Labs) is a plastic gadget with cooled wings in which vibrations are combined with cold therapy. The child will be first made familiar to the device by explaining how it works in simple words, then the child will be allowed to play with Buzzy® in order to familiarize with the device. Buzzy® with freezed wings will be placed extra-orally above the area/cheek where local anesthetic is to be delivered. Local anesthetic will be delivered using conventional 2 mL syringe in the area adjacent to the tooth requiring treatment.
Group III (Conventional Syringe Group): After the patient will be seated on the dental chair, Local anesthetic will be delivered using conventional 2 mL syringe in the area adjacent to the tooth requiring treatment.
The pain assessment will done after the administration of local anesthesia using Wong Baker’s faces pain rating scale and Face, Legs, Activity, Cry, Consolability (FLACC) scale. Data will be collected, tabulated and the values obtained will be statistically analyzed and compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy children with no systemic illness.
- •cooperative child.
- •children requiring local anesthesia.
- •children with no allergy to local anesthesia.
- •children with proper parental consent.
- •children with no skin abrasion.
排除标准
- •Children with known systemic disease.
- •children with behavioural management problems.
- •children with known allergy to local anethesia.
- •children with skin conditions liked eczema or skin abrasions.
- •children below 5 years of age.
结局指标
主要结局
To evaluate and compare the pain perception during administration of local anesthesia using Transcutaneous Electrical Nerve Stimulation and combination of external cold and vibration in pediatric dental patients.
时间窗: The pain assessment will done before and after the administration of local anesthesia
次要结局
- Patient acceptance will be assessed.(Before the administration of Local Anesthesia)
研究者
Dr Nitika Bajaj
Baba Farid University of Health Sciences