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Safety of Local Dental Anesth...

Safety of Local Dental Anesthesia in Patients With Cardiac Channelopathies

Last Updated: 2024-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Channelopathies Brugada Syndrome Long QT Syndrome Ventricular, Tachycardia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Dental restorative procedure

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Dental restorative procedure

Intervention Type PROCEDURE

Interventions

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Dental restorative procedure

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Itamara Lucia Itagiba Neves

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR