Phentolamine Mesylate as a Reversal of Local Anesthesics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 主要终点
- time lip recovery fron local anesthesia
研究概览
简要总结
Oraverse © (Phentolamine mesylate) is a product designed to reverse the effect of local anesthetics used in dentistry. Its main objective is to reduce the postoperative period during which the patient suffers from the lack of sensitivity in the perioral soft tissues, it is an obvious discomfort, a difficulty to speak or eat, and sometimes a risk of self-injury in the lips and / or tongue .
The product was approved by the FDA in 2008 although the introduction in Spain has not occurred until December 2015. There are numerous studies that support its use, its effectiveness and safety, although none of the Spanish population, who have not yet had the opportunity to experience it.
详细描述
PURPOSE OF THE STUDY:
To analyze the response of Oraverse in patients receiving complete oral disinfection treatment, after administration of Lidocaine 2% 1/80000, Articaine 4% 1/200000 or Bupivacaine 0,5% 1:200000 in mandible, in comparison with the contralateral control side.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
We use a program to randomize three groups. Double blind study No sham or placebo
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Previously diagnosticated to receive dental treatment according to Leonformacion's criteria
排除标准
- •Hepatic or renal patient
- •Fertility treatment, pregnancy or lactation
- •Treatment with oral anticoagulants
- •Patients with known allergies to anesthetics, excipients or phentolamine mesylate
- •Patients with previous facial paresthesia
- •Patients who had taken any painkiller or anti-inflammatory the day before
- •Patients in which the anesthetic technique fails or has to be reinforced with more than two carpules
研究组 & 干预措施
lidocaine
lidocaine 2% 1:80000
干预措施: Phentolamine Mesylate 0.235 MG/ML [OraVerse] (Drug)
articaine
articaine 4% 1:200000
干预措施: Phentolamine Mesylate 0.235 MG/ML [OraVerse] (Drug)
bupivacaine
bupivacaine 0,5% 1:200000
干预措施: Phentolamine Mesylate 0.235 MG/ML [OraVerse] (Drug)
结局指标
主要结局
time lip recovery fron local anesthesia
时间窗: 1 day
self reported lip sensitivity by questionaire marking every 15 minutes
次要结局
- Post intervention pain(1 day)
- post intervention bleeding(1 day)
研究者
alejandro gago garcia
Assintant professor
León Formación