Skip to content

Safety of Local Dental Anesthesia in Patients With Cardiac Channelopathies

Safety of Local Dental Anesthesia in Patients With Cardiac Channelopathies

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03182777
Acronym
SLDAPCC
Enrollment
31
Registered
2017-06-09
Start date
2015-05-31
Completion date
2018-08-31
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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.

Interventions

PROCEDUREDental 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

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
No sustained ventricular tachycardiaduring dental proceduresNo life-threatening arrhythmias and clinical signs and symptoms

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026