The Pharmacokinetics of 4% Lidocaine Gel When Applied Topically to the Breasts
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|ClinicalTrials.gov Identifier: NCT00925353|
Recruitment Status : Completed
First Posted : June 22, 2009
Results First Posted : December 23, 2013
Last Update Posted : December 23, 2013
|Condition or disease||Intervention/treatment||Phase|
|Adverse Effects||Drug: 4% lidocaine gel||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Pharmacokinetics of 4% Lidocaine Gel When Applied Topically to the Breasts|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2010|
|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
- 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 ]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 ]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 ]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 ]Percentages of study subjects exhibiting moderate, severe, or life-threatening signs and symptoms at each of the eight time measurements
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|