Safety of Local Dental Anesthesia in Patients With Cardiac Channelopathies (SLDAPCC)

Patients with cardiac channelopathies needing restorative dental treatment will be included in two sessions of the study, using local dental anesthetic: lidocaine 2% with epinephrine and lidocaine 2% without vasoconstrictor. The safety of the use of two cartridges (3.6 mL) will be evaluated. The patients will be their own control and will be assessed by Holter monitoring for 28 hours, blood pressure measurement and anxiety measuring.

Study Overview

• Status: Completed
• Conditions: Brugada Syndrome; Long QT Syndrome; Channelopathies; Ventricular, Tachycardia
• Intervention / Treatment: Procedure: Dental restorative procedure

Detailed Description

Patients of Heart Institute of the University of São Paulo with inherited cardiac channelopathies will be included, considering the criteria for inclusion and non-inclusion, after reading and signing the informed consent.

They will undergo dental restorative treatment in two sessions, in the morning period, with an interval of at least seven days (wash-out) between them, and the patients will be their own control.

In the first session, after randomization, patients will receive lidocaine 2% without vasoconstrictor (LSA) or lidocaine 2% with 1: 100,000 epinephrine (LCA) (cross-over), resulting in two conditions: with adrenaline and without adrenaline.

The randomization of the anesthetic solution will be performed by the main researcher, being blind to the performer researcher and to the patient.

The injected volume will be 3.6 mL (2 cartridges) of the anesthetic solution, using blocking technique of the inferior alveolar nerve.

The patients will be monitored by Holter for 28 hours starting one hour before the procedure, for registration and analysis of cardiac electrical activity during the two sessions. Blood pressure will be monitored with digital sphygmomanometer and anxiety will be measured with Facial Image Scale, both on three occasions: at the beginning of the baseline periods, before starting application of anesthesia and at the end of the proceedings. The results will be analyzed statistically.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05403000
    • Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with any channelopathies below, kept on optimal drug therapy, with or without ICD:

Brugada Syndrome, Long QT Syndrome and Catecholaminergic Polymorphic Ventricular Tachycardia

• Dental caries or unsatisfactory restorations in the mandible, indicating restorative dental treatment

Exclusion Criteria:

• Patients allergic to lidocaine
• Patients undergoing ICD therapy for less than three months
• Patients with recurrent syncope in the last three months
• Patients with sustained arrhythmias documented for less than 3 months
• Have received epinephrine in the last 24 hours

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lidocaine with epinephrine; Application of local dental anesthesia with two cartridges (3,6 mL) of lidocaine 2% with epinephrine 1:100.000 for dental restorative procedures in patients with cardiac channelopathies.	Procedure: Dental restorative procedure; Infiltration of two cartridges (3.6 mL) of local anesthetics with 2% lidocaine with or without epinephrine 1:100,000, in two sessions with an interval of seven days between them, in oral mucosa in patients with cardiac channelopathies.
Active Comparator: Lidocaine; Application of local dental anesthesia with two cartridges (3,6 mL) of lidocaine 2% without vasoconstrictor for dental restorative procedures in patients with cardiac channelopathies.	Procedure: Dental restorative procedure; Infiltration of two cartridges (3.6 mL) of local anesthetics with 2% lidocaine with or without epinephrine 1:100,000, in two sessions with an interval of seven days between them, in oral mucosa in patients with cardiac channelopathies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
No sustained ventricular tachycardia	No life-threatening arrhythmias and clinical signs and symptoms	during dental procedures

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Principal Investigator: Itamara LI Neves, PhD, Instituto do Coração do HCFMUSP; Study Chair: Ana CG Oliveira, S, Instituto do Coração do HCFMUSP; Study Director: Ricardo S Neves, PhD, Instituto do Coração do HCFMUSP; Study Chair: Luciana Sacilotto, S, Instituto do Coração do HCFMUSP; Study Chair: Francisco CC Darrieux, PhD, Instituto do Coração do HCFMUSP; Study Director: Maurício I Scanavacca, PhD, Instituto do Coração do HCFMUSP; Study Chair: Denise Hachul, PhD, Instituto do Coração do HCFMUSP; Study Director: Cesar J Gruppi, PhD, Instituto do Coração do HCFMUSP

Publications and helpful links

General Publications

• Meyer JS, Mehdirad A, Salem BI, Kulikowska A, Kulikowski P. Sudden arrhythmia death syndrome: importance of the long QT syndrome. Am Fam Physician. 2003 Aug 1;68(3):483-8. Erratum In: Am Fam Physician. 2004 May 15;69(10):2324.
• Hersh EV, Giannakopoulos H. Beta-adrenergic blocking agents and dental vasoconstrictors. Dent Clin North Am. 2010 Oct;54(4):687-96. doi: 10.1016/j.cden.2010.06.009.
• Amin AS, Asghari-Roodsari A, Tan HL. Cardiac sodium channelopathies. Pflugers Arch. 2010 Jul;460(2):223-37. doi: 10.1007/s00424-009-0761-0. Epub 2009 Nov 29.
• Kauferstein S, Kiehne N, Neumann T, Pitschner HF, Bratzke H. Cardiac gene defects can cause sudden cardiac death in young people. Dtsch Arztebl Int. 2009 Jan;106(4):41-7. doi: 10.3238/arztebl.2009.0041. Epub 2009 Jan 23.
• Perusse R, Goulet JP, Turcotte JY. Contraindications to vasoconstrictors in dentistry: Part I. Cardiovascular diseases. Oral Surg Oral Med Oral Pathol. 1992 Nov;74(5):679-86. doi: 10.1016/0030-4220(92)90365-w.
• Groban L, Deal DD, Vernon JC, James RL, Butterworth J. Ventricular arrhythmias with or without programmed electrical stimulation after incremental overdosage with lidocaine, bupivacaine, levobupivacaine, and ropivacaine. Anesth Analg. 2000 Nov;91(5):1103-11. doi: 10.1097/00000539-200011000-00011.
• Jowett NI, Cabot LB. Patients with cardiac disease: considerations for the dental practitioner. Br Dent J. 2000 Sep 23;189(6):297-302. doi: 10.1038/sj.bdj.4800750.
• Rochford C, Seldin RD. Review and management of the dental patient with Long QT syndrome (LQTS). Anesth Prog. 2009 Summer;56(2):42-8. doi: 10.2344/0003-3006-56.2.42.
• Buchanan H, Niven N. Validation of a Facial Image Scale to assess child dental anxiety. Int J Paediatr Dent. 2002 Jan;12(1):47-52.
• Naftalin LW, Yagiela JA. Vasoconstrictors: indications and precautions. Dent Clin North Am. 2002 Oct;46(4):733-46, ix. doi: 10.1016/s0011-8532(02)00021-6.
• Pallasch TJ. Vasoconstrictors and the heart. J Calif Dent Assoc. 1998 Sep;26(9):668-73, 676.
• Finder RL, Moore PA. Adverse drug reactions to local anesthesia. Dent Clin North Am. 2002 Oct;46(4):747-57, x. doi: 10.1016/s0011-8532(02)00018-6.
• Goulet JP, Perusse R, Turcotte JY. Contraindications to vasoconstrictors in dentistry: Part III. Pharmacologic interactions. Oral Surg Oral Med Oral Pathol. 1992 Nov;74(5):692-7. doi: 10.1016/0030-4220(92)90367-y.
• Brown RS, Rhodus NL. Epinephrine and local anesthesia revisited. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Oct;100(4):401-8. doi: 10.1016/j.tripleo.2005.05.074. No abstract available.
• Neves RS, Neves IL, Giorgi DM, Grupi CJ, Cesar LA, Hueb W, Grinberg M. Effects of epinephrine in local dental anesthesia in patients with coronary artery disease. Arq Bras Cardiol. 2007 May;88(5):545-51. doi: 10.1590/s0066-782x2007000500008. English, Portuguese.
• Yagiela JA. Adverse drug interactions in dental practice: interactions associated with vasoconstrictors. Part V of a series. J Am Dent Assoc. 1999 May;130(5):701-9. doi: 10.14219/jada.archive.1999.0280.
• Caceres MT, Ludovice AC, Brito FS, Darrieux FC, Neves RS, Scanavacca MI, Sosa EA, Hachul DT. Effect of local anesthetics with and without vasoconstrictor agent in patients with ventricular arrhythmias. Arq Bras Cardiol. 2008 Sep;91(3):128-33, 142-7. doi: 10.1590/s0066-782x2008001500002. English, Portuguese.
• Theodotou N, Cillo JE Jr. Brugada syndrome (sudden unexpected death syndrome): perioperative and anesthetic management in oral and maxillofacial surgery. J Oral Maxillofac Surg. 2009 Sep;67(9):2021-5. doi: 10.1016/j.joms.2009.04.043. No abstract available.
• Ackerman MJ, Khositseth A, Tester DJ, Hejlik JB, Shen WK, Porter CB. Epinephrine-induced QT interval prolongation: a gene-specific paradoxical response in congenital long QT syndrome. Mayo Clin Proc. 2002 May;77(5):413-21. doi: 10.4065/77.5.413.
• Wynn RL. Articaine 4% with 1:200,000 epinephrine: an acceptable option for patients with long QT syndrome. Gen Dent. 2007 May-Jun;55(3):176-8. No abstract available.
• Middlehurst RJ, Gibbs A, Walton G. Cardiovascular risk: the safety of local anesthesia, vasoconstrictors, and sedation in heart disease. Anesth Prog. 1999 Fall;46(4):118-23.
• Fujiki A, Nishida K, Mizumaki K, Nagasawa H, Shimono M, Inoue H. Spontaneous onset of torsade de pointes in long-QT syndrome and the role of sympathovagal imbalance. Jpn Circ J. 2001 Dec;65(12):1087-90. doi: 10.1253/jcj.65.1087.
• Monteforte N, Napolitano C, Priori SG. Genetics and arrhythmias: diagnostic and prognostic applications. Rev Esp Cardiol (Engl Ed). 2012 Mar;65(3):278-86. doi: 10.1016/j.recesp.2011.10.008. Epub 2012 Jan 14. English, Spanish.
• Ernesto C, Cruz FE, Lima FS, Coutinho JL, Silva R, Urmenyi TP, Carvalho AC, Rondinelli E. Investigation of ion channel gene variants in patients with long QT syndrome. Arq Bras Cardiol. 2011 Mar;96(3):172-8. doi: 10.1590/s0066-782x2011005000015. Epub 2011 Feb 4. English, Portuguese, Spanish.
• Oliveira ACG, Neves ILI, Sacilotto L, Olivetti NQS, Santos-Paul MAD, Montano TCP, Carvalho CMA, Wu TC, Grupi CJ, Barbosa SA, Pastore CA, Samesima N, Hachul DT, Scanavacca MI, Neves RS, Darrieux FCC. Is It Safe for Patients With Cardiac Channelopathies to Undergo Routine Dental Care? Experience From a Single-Center Study. J Am Heart Assoc. 2019 Aug 6;8(15):e012361. doi: 10.1161/JAHA.119.012361. Epub 2019 Jul 19.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: October 15, 2015
• First Submitted That Met QC Criteria: June 7, 2017
• First Posted (Actual): June 9, 2017

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: genetic testing; anesthesia, local; dentistry; channelopathies; arrhythmias, cardiac; death, sudden; electrocardiography, ambulatory
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Syndrome; Tachycardia; Brugada Syndrome; Long QT Syndrome; Channelopathies
• Other Study ID Numbers: Odonto-Canalopatias

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After thesis defense, the IPD will be available on the Portal Digital Library of Theses and Dissertations of the University of São Paulo (http://www.teses.usp.br/index.php?option=com_jumi&fileid=12&Itemid=77&lang=pt-br), in a PDF file.