Status:
COMPLETED
The Pharmacokinetics of 4% Lidocaine Gel When Applied Topically to the Breasts
Lead Sponsor:
Mountain States Tumor and Medical Research Institute
Conditions:
Adverse Effects
Eligibility:
FEMALE
35+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to test the hypothesis that one-time application of 4% lidocaine gel (TOPICAINE) on the skin of the breasts and chest wall as recommended for pre-medication to reduce disc...
Eligibility Criteria
Inclusion
- 35 years and older
- intact skin on breasts and chest wall
Exclusion
- sensitivity or allergy to lidocaine
- liver or kidney dysfunction
- pregnant
- breast feeding
- currently smoke or chew tobacco
- used lidocaine products within 48 hours of baseline lab, EKG, or gel application
- exhibit neurological or cardiac signs or symptoms prior to gel application
- are taking antiarrythmic medications, ciprofloxacin, erythromycin products, or oral contraceptives
- history of Wolffe-Parkinson-White Syndrome (WPW) or congestive heart failure
- heart rate below 60 or above 100 beats per minute
- systolic blood pressure below 95 or above 180 mm Hg
- PR interval greater 200 msec, QRS duration greater than 120 msec, QTc greater than 450 msec, or evidence of WPW on EKG
- have an automatic implantable cardioverter defibrillator (AICD) or cardiac pacemaker
- have had cancer, surgery, trauma, or myocardial infarction in the past 6 months
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00925353
Start Date
January 1 2010
End Date
February 1 2010
Last Update
December 23 2013
Active Locations (1)
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1
St. Luke's Mountain States Tumor Institute
Boise, Idaho, United States, 83712