NCT03740386

Phentolamine Mesylate as a Reversal of Local Anesthesics

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: León Formación · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Anesthesia, Local

Interventions

Type	Name	Description
DRUG	Phentolamine Mesylate 0.235 MG/ML [OraVerse]	compare effect of phentolamine mesylate in three arms

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-11-09
• Completion: 2018-11-09
• First posted: 2018-11-14
• Last updated: 2018-11-14