The Pharmacokinetics of 4% Lidocaine Gel When Applied Topically to the Breasts

Phase 4 Completed 13 enrolled Mountain States Tumor and Medical Research Institute

NaSingle-groupOpen-labelTreatment

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 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).

Timeline

Start: 2010-01
Primary completion: 2010-02
Completion: 2010-02

Publications

Results Lambertz CK, Johnson CJ, Montgomery PG, Maxwell JR, Fry SJ. Toxicity of topical lidocaine applied to the breasts to reduce discomfort during screening mammography. J Anaesthesiol Clin Pharmacol. 2012 Apr;28(2):200-4. doi: 10.4103/0970-9185.94859.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lidocaine	Other / unclassified	4 %	Topical

Indications

No indication recorded.