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Dental Anesthesia in Pregnant Women With Rheumatic Heart Disease

NCT00482573 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2008-06-05

No results posted yet for this study

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.

Conditions

  • Rheumatic Heart Disease
  • Pregnancy
  • Dental Caries

Interventions

PROCEDURE

Dental local anesthesia

* 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)

PROCEDURE

Dental local anesthesia

* 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)

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Itamara LI Neves, PhD · Heart Institute (InCor) of University of São Paulo Medical School - Sao Paulo, Brazil

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2005-07-31
Completion
2006-01-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00482573 on ClinicalTrials.gov