Phentolamine Mesylate as a Reversal of Local Anesthesics

Anesthesia, Local Clinical Trial

Official title:

Phentolamine Mesylate as a Reversal of Local Anesthesics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03740386
• Other study ID #: LeonFormacion
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: November 9, 2018

Study information

• Verified date: November 2018
• Source: León Formación
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 9, 2018
• Est. primary completion date: November 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local

Intervention

Drug:
• Phentolamine Mesylate 0.235 MG/ML [OraVerse]
compare effect of phentolamine mesylate in three arms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
León Formación

References & Publications (9)

Daubländer M, Liebaug F, Niedeggen G, Theobald K, Kürzinger ML. Effectiveness and safety of phentolamine mesylate in routine dental care. J Am Dent Assoc. 2017 Mar;148(3):149-156. doi: 10.1016/j.adaj.2016.11.017. Epub 2017 Jan 23. — View Citation

Elmore S, Nusstein J, Drum M, Reader A, Beck M, Fowler S. Reversal of pulpal and soft tissue anesthesia by using phentolamine: a prospective randomized, single-blind study. J Endod. 2013 Apr;39(4):429-34. doi: 10.1016/j.joen.2012.12.024. Epub 2013 Feb 11. — View Citation

Fowler S, Nusstein J, Drum M, Reader A, Beck M. Reversal of soft-tissue anesthesia in asymptomatic endodontic patients: a preliminary, prospective, randomized, single-blind study. J Endod. 2011 Oct;37(10):1353-8. doi: 10.1016/j.joen.2011.06.019. Epub 2011 — View Citation

Hersh EV, Lindemeyer RG. Phentolamine mesylate for accelerating recovery from lip and tongue anesthesia. Dent Clin North Am. 2010 Oct;54(4):631-42. doi: 10.1016/j.cden.2010.06.004. Review. — View Citation

Hersh EV, Moore PA, Papas AS, Goodson JM, Navalta LA, Rogy S, Rutherford B, Yagiela JA; Soft Tissue Anesthesia Recovery Group. Reversal of soft-tissue local anesthesia with phentolamine mesylate in adolescents and adults. J Am Dent Assoc. 2008 Aug;139(8): — View Citation

Laviola M, McGavin SK, Freer GA, Plancich G, Woodbury SC, Marinkovich S, Morrison R, Reader A, Rutherford RB, Yagiela JA. Randomized study of phentolamine mesylate for reversal of local anesthesia. J Dent Res. 2008 Jul;87(7):635-9. — View Citation

Moore PA, Hersh EV, Papas AS, Goodson JM, Yagiela JA, Rutherford B, Rogy S, Navalta L. Pharmacokinetics of lidocaine with epinephrine following local anesthesia reversal with phentolamine mesylate. Anesth Prog. 2008 Summer;55(2):40-8. doi: 10.2344/0003-30 — View Citation

Prados-Frutos JC, Rojo R, González-Serrano J, González-Serrano C, Sammartino G, Martínez-González JM, Sánchez-Monescillo A. Phentolamine mesylate to reverse oral soft-tissue local anesthesia: A systematic review and meta-analysis. J Am Dent Assoc. 2015 Oc — View Citation

Tavares M, Goodson JM, Studen-Pavlovich D, Yagiela JA, Navalta LA, Rogy S, Rutherford B, Gordon S, Papas AS; Soft Tissue Anesthesia Reversal Group. Reversal of soft-tissue local anesthesia with phentolamine mesylate in pediatric patients. J Am Dent Assoc. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time lip recovery fron local anesthesia	self reported lip sensitivity by questionaire marking every 15 minutes	1 day
Secondary	Post intervention pain	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	1 day
Secondary	post intervention bleeding	clinical assesment of post intervention bleeding when using phentolamine mesylate	1 day