Comparative Evaluation of Effectiveness of Benzocaine Gel & Ice for Pain Management in Children During Local Anaesthetic Administration By CCLD, A Randomised Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. To evaluate and compare objective pain, measured by Modified Behavioral Pain Scale during administration of local anaesthetic via CCLD with the application of topical agent, ice and benzocaine gel.
研究概览
简要总结
This study is a Split Mouth, Single Blinded, Randomized Controlled Clinical Trial. Healthy children aged between 5 to 10 years requiring maxillary bilateral local anaesthesia for dental procedures will be selected. Patient will be selected from OPD based on inclusion criteria. there will be two groups. Group I, Local anaesthetic administration with the CCLD after the application of ice as a topical agent. Group II – Local anaesthetic administration with the CCLD after the application of benzocaine gel as topical agent. At first visit, half of the population according to randomization will be received intervention treatment. After 7 days same patients will be recalled and control treatment will provide. The other half of the population, according to randomization, will receive the control treatment, and after 7 days, the same patients will be recalled, and intervention treatment will be provided. The objective pain will be evaluated by Modified Behavioral Pain Scale. Subjective pain will be analysed by Wong-Baker Faces pain rating scale.
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
- 5.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢ Healthy children (ASA I) of age 5 to 10 years • Children requiring maxillary buccal infiltration anaesthesia for dental procedures (extraction, restorations, crown preparation, pulp therapy) in both the quadrants.
- •â€¢ Frankl’s behaviour rating grade III or IV • Children not taking any analgesics or other drugs that would influence their perception of pain • Completion of informed consent to participate in the study by parents.
排除标准
- •â€¢ Medically compromised condition • Any allergy to local anaesthesia • Active pathology at the site of injection • Prior history of dental treatment • Frankl’s behaviour rating Grade I or II • Children with cold hyper sensitivity.
结局指标
主要结局
1. To evaluate and compare objective pain, measured by Modified Behavioral Pain Scale during administration of local anaesthetic via CCLD with the application of topical agent, ice and benzocaine gel.
时间窗: At the time of injection
2. To evaluate and compare subjective pain, measured by the Wong-Baker Faces pain rating scale, after administration of local anaesthetic via CCLD with the application of topical agent, ice and benzocaine gel.
时间窗: At the time of injection
次要结局
- 3. To evaluate and compare the comfort of patient during administration of local anaesthetic via CCLD with the application of topical agent, ice and benzocaine gel.(At the time of injection)
研究者
Dr Anija C K
Government Dental College and Hospital, Nagpur