NCT03182777

Safety of Local Dental Anesthesia in Patients With Cardiac Channelopathies

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-05-01
• Primary completion: 2018-08-01
• Completion: 2018-08-01
• First posted: 2017-06-09
• Last updated: 2024-04-09

Locations

1 site across 1 country: Brazil