A COMPARATIVE EVALUATION OF THE EFFICACY, PAIN PERCEPTION, HEMODYNAMIC CHANGES AND ADVERSE EFFECTS OF WARM LOCAL ANAESTHETIC SOLUTION DELIVERED ON PRE-COOLED INJECTION SITES WITH THE CONVENTIONAL LOCAL ANAESTHETIC TECHNIQUE IN 7 - 9 YEARS CHILDREN: AN IN VIVO RANDOMIZED SPLIT MOUTH CLINICAL TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Administration of warm local anaesthetic solution on pre-cooled injection sites may create reduction in pain perception and may provide better anesthesia in children when compared to conventional local anaesthetic technique during inferior alveolar nerve block anesthesia
研究概览
简要总结
This is an in vivo randomized controlled experimental split mouth study, involving 70 children in the age group of 7 – 9 yrs which will require bilateral anaesthesia for different dental procedures in primary mandibular molars. By a split mouth design, selected children will be randomly allocated to receive 2% lignocaine with either technique a or b during the first or second appointment of treatment procedure.
Technique A: During the visit, precooling of the site of injection was done up to 2 mins and after that warmed local anaesthetic solution was administered on one side of the arch using 2 % lignocaine.
Technique B: During the visit, lidocaine hydrochloride 2% topical gel being applied on the site of injection and local anesthesia will be administered by the conventional technique using 2% lignocaine. The operative procedure carried out will be similar for all children and will be completed in the same appointment and by the same operator. The subject will be blinded for the drug being used and will not have any involvement with testing the outcome. A minimum of 1-week time difference will be maintained between the two appointments to avoid the effect of carry over phenomenon in children. After the administration of local anesthesia, selected children will be evaluated on the following parameters: Pain perception, onset of anesthesia, duration of anesthesia, hemodynamic changes and adverse effects. The expected conclusion of this study will be that administration of warm local anaesthetic solution on pre-cooled injection sites may create reduction in pain perception and may provide better anesthesia with less adverse effects in children when compared to conventional local anaesthetic technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator 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
- •Medically fit children aged between 7 to 9 years.
- •Children who are mentally capable of communication and those who can follow the instructions and able to interpret the pain perception appropriately.
- •Having mandibular primary molar tooth that require extraction or pulp therapy bilaterally or requiring at least two clinical sessions of pulp therapy procedures.
- •Requiring bilateral inferior alveolar nerve block, without any history of receiving dental injections.
- •Children, who are cooperative enough to undergo dental procedures
- •Parental informed written consent provided
- •Tooth which will give a baseline reading on pulp tester before administration of local anesthetic.
排除标准
- •Patients with acute signs and symptoms requiring emergency treatment, with previous painful dental experience, and who were medically compromised were excluded from the study
- •History of any post-traumatic stress disorders or specific phobia related to dental settings.
- •History of systemic mental or physical disorders.
- •Children with allergic reactions to lidocaine.
- •Children with cold hypersensitivity and underlying vascular or immunological diseases were excluded from the study.
结局指标
主要结局
Administration of warm local anaesthetic solution on pre-cooled injection sites may create reduction in pain perception and may provide better anesthesia in children when compared to conventional local anaesthetic technique during inferior alveolar nerve block anesthesia
时间窗: Immediately after administration of local anesthesia
次要结局
- Administration of warm local anaesthetic solution on pre-cooled injection sites may provide less adverse effects and hemodynamic changes when compared to conventional local anesthetic technique(Hemodynamic changes will be evaluated immediately at the time of administration of local anesthesia and adverse effects will be evaluated after 24 hours)