Comparative evaluation of pain perception and anxiety level during the administration of inferior alveolar nerve block using Computer Controlled Local Anesthetic Delivery System CCLADS and conventional local anesthetic delivery system in children a randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1. Anxiety level (before and after administration of nerve block).
研究概览
简要总结
This study will be conducted at SCB Dental College and Hospital, Cuttack, Odisha, India to compare and evaluate pain perception and anxiety level associated with administration of Inferior Alveolar Nerve Block (IANB) using Computer Controlled Local Anesthetic Delivery System (CCLADS) and Conventional Local Anesthetic Delivery System in children. After thorough clinical examinations and relevant investigations, indicated dental procedure will be performed on children in which Inferior Alveolar Nerve Block (IANB) will be administered by either using conventional syringe or SlowJec, a Computer Controlled Local Anesthetic Delivery System (CCLADS). The results obtained will be statistically evaluated in further course of time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children requiring inferior alveolar nerve block injections during dental procedures.
- •Children displaying Frankl behaviour ratings 3 and
- •Children who have never been administered with inferior alveolar nerve block.
排除标准
- •Children with learning and audio-visual impairment.
- •Children with any systemic diseases.
- •Children with a pacemaker.
- •Children who are allergic to local anesthetic agents.
- •Children whose parents are not willing to participate in the study.
结局指标
主要结局
1. Anxiety level (before and after administration of nerve block).
时间窗: 1. Before administration of nerve block. | 2. After administration of nerve block.
2. Pain perception immediately after administration of nerve block.
时间窗: 1. Before administration of nerve block. | 2. After administration of nerve block.
次要结局
- 1. Heart rate(2. Patient comfort level)
研究者
Dr Liza Swain
SCB dental college and hospital