Phentolamine Mesylate as a Reversal of Local Anesthesics

León Formación

Status: Completed

Conditions: Anesthesia, Local

Treatments: Drug: Phentolamine Mesylate 0.235 MG/ML [OraVerse]

Study type: Interventional

Funder types: Other

Identifiers

NCT03740386

LeonFormacion

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Previously diagnosticated to receive dental treatment according to Leonformacion's criteria

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

90 participants in 3 patient groups

lidocaine

Experimental group

Description:

lidocaine 2% 1:80000

Treatment:

Drug: Phentolamine Mesylate 0.235 MG/ML [OraVerse]

articaine

Experimental group

Description:

articaine 4% 1:200000

Treatment:

Drug: Phentolamine Mesylate 0.235 MG/ML [OraVerse]

bupivacaine

Experimental group

Description:

bupivacaine 0,5% 1:200000

Treatment:

Drug: Phentolamine Mesylate 0.235 MG/ML [OraVerse]