CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 31 enrolled
Drug / intervention
Dental local anesthesia +1 moreprocedure
Likely dose
Not stated in record
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Search/NCT00482573
NCT00482573Phase 1Completed

Maternal-Fetal Monitoring of Patients With Rheumatic Heart Disease During Dental Procedure Under Local Anesthesia

University of Sao Paulo·interventional·Posted Jun 5, 2007·Updated Jun 5, 2008

In Brief

A Phase 1 clinical trial evaluating Dental local anesthesia for Rheumatic Heart Disease and 2 related conditions. Completed, enrolled 31 participants across 1 site.

Detailed Summary

The hemodynamic parameters of 31 pregnant women with rheumatic valve disease, undergoing restorative dentistry under local anesthesia with 2% solution of lidocaine, divided in two groups, with (Group LE) and without 1:100,000 epinephrine solution (Group LNE), were studied by 24-hour ambulatory electrocardiographic monitoring, intermittent blood pressure monitoring and continuous cardiotocography, during three standard time periods. A significant decrease in the values of maternal heart rate was seen during the procedure, in comparison with the other two time periods in the two groups, as well as, the occurrence of cardiac arrhythmia in 9 (29.1%) patients, being 7 (41.8%) of them in the group receiving epinephrine anesthesia. We conclude the use of 2% lidocaine in association with epinephrine proved safe during dental procedure in pregnant women with rheumatic valve disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil

Timeline

Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 5, 2007
Enrollment StartApr 1, 2004
Primary CompletionJul 1, 2005
Study CompletionJan 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.1 years ago

Interventions

Dental local anesthesiaprocedure

* 2% lidocaine solution with epinephrine 1:100,000 * infusion of 1,8 mL (one cartridge) * Technic: modified anesthesia of the periodontal ligament (PDLm injection) was performed applying The Wand II Computerized System (Milestone International)

Dental local anesthesiaprocedure

* 2% lidocaine solution without vasoconstrictor * infusion of 1,8 mL (one cartridge) * Technic: modified anesthesia of the periodontal ligament (PDLm injection) was performed applying The Wand II Computerized System (Milestone International)