Safety of Local Dental Anesthesia in Patients With Cardiac Channelopathies

NCT03182777 | Completed DMC

• 1 other identifier: Odonto-Canalopatias
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Channelopathies; Brugada Syndrome; Long QT Syndrome; Ventricular, Tachycardia

Keywords

arrhythmias, cardiac; channelopathies; death, sudden; genetic testing; electrocardiography, ambulatory; anesthesia, local; dentistry

Outcome Measures

Primary Outcomes (1)

• No sustained ventricular tachycardia

  No life-threatening arrhythmias and clinical signs and symptoms

  during dental procedures

Study Arms (2)

Lidocaine with epinephrine

ACTIVE COMPARATOR

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

Lidocaine

ACTIVE COMPARATOR

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

Interventions

Dental restorative procedure 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.

Lidocaine; Lidocaine with epinephrine

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, 05403000, Brazil

Location

Related Publications (25)

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• 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.

  PMID: 31319747 DERIVED

MeSH Terms

Conditions

Channelopathies; Brugada Syndrome; Long QT Syndrome; Tachycardia, Ventricular; Arrhythmias, Cardiac; Death, Sudden

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Tachycardia; Death

Study Officials

• Itamara LI Neves, PhD

  Instituto do Coração do HCFMUSP

  PRINCIPAL INVESTIGATOR

• Ana CG Oliveira, S

  Instituto do Coração do HCFMUSP

  STUDY CHAIR

• Ricardo S Neves, PhD

  Instituto do Coração do HCFMUSP

  STUDY DIRECTOR

• Luciana Sacilotto, S

  Instituto do Coração do HCFMUSP

  STUDY CHAIR

• Francisco CC Darrieux, PhD

  Instituto do Coração do HCFMUSP

  STUDY CHAIR

• Maurício I Scanavacca, PhD

  Instituto do Coração do HCFMUSP

  STUDY DIRECTOR

• Denise Hachul, PhD

  Instituto do Coração do HCFMUSP

  STUDY CHAIR

• Cesar J Gruppi, PhD

  Instituto do Coração do HCFMUSP

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: June 9, 2017
• Study Start: May 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)