Safety of Local Dental Anesthesia in Patients With Cardiac Channelopathies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- No sustained ventricular tachycardia
研究概览
简要总结
Patients with cardiac channelopathies needing restorative dental treatment will be included in two sessions of the study, using local dental anesthetic: lidocaine 2% with epinephrine and lidocaine 2% without vasoconstrictor. The safety of the use of two cartridges (3.6 mL) will be evaluated. The patients will be their own control and will be assessed by Holter monitoring for 28 hours, blood pressure measurement and anxiety measuring.
详细描述
Patients of Heart Institute of the University of São Paulo with inherited cardiac channelopathies will be included, considering the criteria for inclusion and non-inclusion, after reading and signing the informed consent.
They will undergo dental restorative treatment in two sessions, in the morning period, with an interval of at least seven days (wash-out) between them, and the patients will be their own control.
In the first session, after randomization, patients will receive lidocaine 2% without vasoconstrictor (LSA) or lidocaine 2% with 1: 100,000 epinephrine (LCA) (cross-over), resulting in two conditions: with adrenaline and without adrenaline.
The randomization of the anesthetic solution will be performed by the main researcher, being blind to the performer researcher and to the patient.
The injected volume will be 3.6 mL (2 cartridges) of the anesthetic solution, using blocking technique of the inferior alveolar nerve.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with any channelopathies below, kept on optimal drug therapy, with or without ICD:
- •Brugada Syndrome, Long QT Syndrome and Catecholaminergic Polymorphic Ventricular Tachycardia
- •Dental caries or unsatisfactory restorations in the mandible, indicating restorative dental treatment
排除标准
- •Patients allergic to lidocaine
- •Patients undergoing ICD therapy for less than three months
- •Patients with recurrent syncope in the last three months
- •Patients with sustained arrhythmias documented for less than 3 months
- •Have received epinephrine in the last 24 hours
结局指标
主要结局
No sustained ventricular tachycardia
时间窗: during dental procedures
No life-threatening arrhythmias and clinical signs and symptoms
次要结局
未报告次要终点
研究者
Itamara Lucia Itagiba Neves
Principal Investigator
University of Sao Paulo General Hospital