Pharmacokinetics of lidocaine delivered from a transmucosal patch in children.

The DentiPatch lidocaine transoral delivery system (Noven Pharmaceuticals) is indicated for mild topical anesthesia of mucosal membranes in the mouth. The DentiPatch is a mucoadhesive patch containing 46.1 mg of lidocaine (20% concentration). Current studies in adults report that DentiPatch application produces very low plasma concentrations of lidocaine. However, it is not known what plasma levels are obtained when the same dosage is used in children. The purpose of this study was to determine whether the plasma lidocaine concentrations generated by the DentiPatch are within a safe range for children. The sample in this study was 11 children aged 2-7 years requiring general anesthesia for comprehensive dental care. A lidocaine DentiPatch was placed on the buccal mucosa above the maxillary incisors for 5 minutes. Blood samples were drawn before placing the DentiPatch and at various time intervals after removing it. Blood samples were analyzed by fluorescence polarization immunoassay to determine the plasma concentrations of lidocaine and its major metabolite, monoethylglycinexylidide. The lidocaine and monoethylglycinexylidide absorbed from the DentiPatch did not reach toxic plasma levels in children. However, plasma concentrations were much higher than in adults and were high enough to require inclusion in the calculation of total lidocaine administered to a pediatric patient.