Comparative evaluation of pain perception and behavior of 7-9 year old children during local anesthesia administration using starpen and conventional local anesthesia delivery systems: a randomized clinical trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Reduction in pain perception
研究概览
简要总结
The present study is a single-blind, two-armed, parallel-group, randomized clinical trial. Forty - eight participants in the age group of 7-9 years will be recruited from the outpatient department (OPD) of the Department of Pediatric and Preventive Dentistry, Sri Rajiv Gandhi College of Dental Sciences & Hospital, Bengaluru, Karnataka. After obtaining the written informed consent, the participants will be randomly allocated into two groups by the block randomization method using a computer-generated list. Allocation will be performed by a trial-independent individual. Groups: Group I: (Experimental group, n = 24) will receive local anesthesia with the aid of a Starpen (WOODPECKER)® dental anesthesia device. Group II: (Control group, n = 24) will receive local anesthesia with the aid of a conventional local anesthetic syringe. Before the commencement of the treatment, all the participants’ heart rates will be recorded using a finger pulse oximeter. The local anesthetic agent and the needle used will be standardized, i.e.,2% lignocaine with 1:80000 adrenaline will be administered using a 30 gauge needle. The topical anesthetic gel will be applied and left in contact with the soft tissue for 1 minute after drying the tissues with 2x2 cm gauze. Group I: for the supra periosteal anesthesia using Starpen (WOODPECKER)®, the procedure will be followed as specified by the manufacturer. Group II: Supraperiosteal injection will be given using the conventional metal syringe. During injection, the heart rate and objective assessment of the pain-related behavior of the child will be recorded following both buccal and palatal infiltration individually using the Sound, Eye, and Motor (SEM) scale. The pain perception of the participants will be assessed subjectively following injection using the Wong-Baker FACES pain rating scale. The objective and subjective assessment will be done by two trained trial-independent evaluators separately.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 7.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •Children in the age group of 7-9 years requiring extraction of teeth using supra periosteal local anesthesia.
- •No history of an unpleasant experience in medical or dental settings.
- •No previous history of intra-oral injections.
- •Only cooperative children with a positive behavior rating of 3 or 4 on Frankl’s behavior rating scale.
- •No cognitive impairment.
- •Patients with American Association of Anesthesiologists-I (ASA I) health status.
- •Written informed consent from parents.
排除标准
- •Medically and mentally compromised children.
- •Active sites of pathosis in the site of injection.
- •Family history of allergy to local anesthesia.
- •Unwilling and unaccompanied children.
结局指标
主要结局
Reduction in pain perception
时间窗: Baseline
次要结局
- Improved behaviour(5 minutes after local anesthesia administration)
研究者
Sanket Sanger
Sri Rajiv Gandhi College of Dental Sciences and Hospital Bangalore