Phentolamine Mesylate as a Reversal of Local Anesthesics

Not Applicable

Completed

• Conditions: Anesthesia, Local
• Interventions: Drug: Phentolamine Mesylate 0.235 MG/ML [OraVerse]

• Registration Number: NCT03740386
• Lead Sponsor: León Formación

Brief 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.

Study Timeline

• Study Start: 2016-01-01
• Status Verified: 2018-11
• Primary Completion: 2018-11-09
• Study Completion: 2018-11-09
• Study First Submitted: 2018-11-09
• Study First Submitted QC: 2018-11-10
• Last Update Submitted: 2018-11-10
• Study First Posted: 2018-11-14
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
bupivacaine	Phentolamine Mesylate 0.235 MG/ML [OraVerse]	bupivacaine 0,5% 1:200000
lidocaine	Phentolamine Mesylate 0.235 MG/ML [OraVerse]	lidocaine 2% 1:80000
articaine	Phentolamine Mesylate 0.235 MG/ML [OraVerse]	articaine 4% 1:200000

Primary Outcome Measures

Name	Time	Method
time lip recovery fron local anesthesia	1 day	self reported lip sensitivity by questionaire marking every 15 minutes

Secondary Outcome Measures

Name	Time	Method
Post intervention pain	1 day	visual analogue scale to measure pain: Line ranged from 1 to 10 units where 1 means no pain at all and 10 means the worst imaginable pain. Lower levels are good outcomes
post intervention bleeding	1 day	clinical assesment of post intervention bleeding when using phentolamine mesylate