The Pharmacokinetics of 4% Lidocaine Gel When Applied Topically to the Breasts
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 discomfort during screening mammography does not result in adverse effects, electrocardiogram (EKG) changes, or systemically toxic plasma concentration of lidocaine or its principal metabolite, monoethylglycinexylidide (MEGX).
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Pharmacokinetics of 4% Lidocaine Gel When Applied Topically to the Breasts|
- Pharmacokinetic Parameters Based on Plasma Concentration of Lidocaine and MEGX in Nanograms/Milliliter. [ Time Frame: Prior to gel application, and at 30 min, 60 min, and 2, 3, 4, 6, and 8 hours after ] [ Designated as safety issue: Yes ]Plasma concentration of lidocaine and MEGX in nanograms/milliliter were measured prior to one-time application of 4% lidocaine gel on the skin of the breasts and chest wall as recommended for use as as pre-medication to reduce discomfort during screening mammography, and at 30 minutes, 60 minutes, and 2, 3, 4, 6, and 8 hours. Due to the high frequency of nondetectable values, pharmacokinetic parameters could not be estimated. Measurements at all time points were grouped together to select a median.
- EKG Changes [ Time Frame: Prior to gel application and 3 hours after ] [ Designated as safety issue: Yes ]The PR interval (msec), QRS duration (msec), and QTc interval (msec) were compared between the baseline and subsequent EKG using paired t-tests.
- Variation of Heart Rate (Bpm), Respiratory Rate (Respirations Per Minute, Rpm), Systolic Blood Pressure (mm Hg), and Diastolic Blood Pressure (mm Hg) Over Time. [ Time Frame: Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after ] [ Designated as safety issue: Yes ]Variation of heart rate (bpm), respiratory rate (respirations per minute, rpm), systolic blood pressure (mm Hg), and diastolic blood pressure (mm Hg) over time was assessed using generalized linear mixed models with time modeled as a fixed effect and study subject modeled as a random effect.
- Frequencies of Moderate, Severe, or Life-threatening Side Effects [ Time Frame: Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after ] [ Designated as safety issue: Yes ]Percentages of study subjects exhibiting moderate, severe, or life-threatening signs and symptoms at each of the eight time measurements
|Study Start Date:||January 2010|
|Study Completion Date:||February 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
|Experimental: lidocaine gel||
Drug: 4% lidocaine gel
1 ounce 4% lidocaine gel on skin of breasts and chest wall for 1 hour under occlusion, then removed with warm water
Other Name: TOPICAINE
Please refer to this study by its ClinicalTrials.gov identifier: NCT00925353
|United States, Idaho|
|St. Luke's Mountain States Tumor Institute|
|Boise, Idaho, United States, 83712|
|Principal Investigator:||Colleen K Lambertz, MSN, FNP||St. Luke's Mountain States Tumor Institute|