Safety of Local Dental Anesthesia in Patients With Cardiac Channelopathies

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

Interventions

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.

Sponsors & Collaborators

• Fundação de Amparo à Pesquisa do Estado de São Paulo

  collaborator OTHER_GOV

• University of Sao Paulo General Hospital

  lead OTHER

Principal Investigators

• Itamara LI Neves, PhD · Instituto do Coração do HCFMUSP

• Ana CG Oliveira, S · Instituto do Coração do HCFMUSP

• Ricardo S Neves, PhD · Instituto do Coração do HCFMUSP

• Luciana Sacilotto, S · Instituto do Coração do HCFMUSP

• Francisco CC Darrieux, PhD · Instituto do Coração do HCFMUSP

• Maurício I Scanavacca, PhD · Instituto do Coração do HCFMUSP

• Denise Hachul, PhD · Instituto do Coração do HCFMUSP

• Cesar J Gruppi, PhD · Instituto do Coração do HCFMUSP

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

6 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-05-31

Primary Completion

2018-08-31

Completion

2018-08-31

Countries

• Brazil

Study Locations