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Objective: To evaluate local and systemic safety of bilateral iontophoretic administration of lidocaine with epinephrine or lidocaine alone to the tympanic membrane (TM).

Study Design: A randomized, double-blind, two-arm study was conducted at a single center. Healthy adults were randomized to bilateral iontophoretic treatment with 2% lidocaine, 1:100,000 epinephrine, or 2% lidocaine (control). Otoscopy, cranial nerve examination, tympanometry, and audiometry safety evaluations were conducted before and 3-days post-procedure. Systemic safety was evaluated via analysis of vital signs taken before and up to 120 minutes post-iontophoresis, and blood samples collected before and up to 230 minutes post-iontophoresis.

Results: Twenty-five subjects were treated with bilateral iontophoresis of either lidocaine and epinephrine (n = 15 subjects) or lidocaine alone (n = 10). Mean plasma epinephrine concentrations for both groups remained within the normal range for endogenous epinephrine. Mean plasma concentrations of lidocaine were not statistically different between groups, ranging from 0.245 to 2.28 ng/ml after administration of lidocaine with epinephrine (immediate post-iontophoresis to 230 min post-iontophoresis), compared with 1.35 to 2.14 ng/ml after administration of lidocaine alone. The presence of epinephrine slowed the systemic absorption of lidocaine. Lidocaine levels (Cmax 2.24 ng/ml) were approximately 2000-fold lower than the threshold for minor lidocaine toxicity. No device-, procedure- or drug-related adverse events were reported.

Conclusion: The local and systemic safety of bilateral iontophoretic delivery of 2% lidocaine, 1:100,000 epinephrine to the TM was demonstrated by low plasma levels of drug and absence of both serious and non-serious device-, procedure-, or drug-related adverse events.

Competing Interests: Conflicts of Interest Statement: Tusker Medical, Inc., a subsidiary of Smith + Nephew, provided financial and logistic sponsorship for the study as well as data monitoring, data analysis, and assistance in drafting the manuscript. L.J.E. is an employee of Tusker Medical, Inc. Charles A Syms III is a scientific advisory board member and consultant for Tusker Medical, Inc.

Titel:	Pharmacokinetics of Single Dose Lidocaine and Epinephrine Following Iontophoresis of the Tympanic Membrane in a Double-Blinded Randomized Trial.
Autor/in / Beteiligte Person:	England, LJ ; Syms CA 3rd ; York, C
Zeitschrift:	Otology & neurotology : official publication of the American Otological Society, Jg. 42 (2021-08-01), Heft 7, S. 1095-1103
Veröffentlichung:	Hagerstown, MD : Lippincott Williams & Wilkins, c2001-, 2021
Medientyp:	academicJournal
ISSN:	1537-4505 (electronic)
DOI:	10.1097/MAO.0000000000003128
Schlagwort:	Adult Anesthetics, Local Double-Blind Method Epinephrine Humans Tympanic Membrane Iontophoresis Lidocaine
Sonstiges:	Nachgewiesen in: MEDLINE Sprachen: English Publication Type: Journal Article; Randomized Controlled Trial Language: English [Otol Neurotol] 2021 Aug 01; Vol. 42 (7), pp. 1095-1103. MeSH Terms: Iontophoresis* ; Lidocaine* ; Adult ; Anesthetics, Local ; Double-Blind Method ; Epinephrine ; Humans ; Tympanic Membrane References: Otitis Media, NIDCD. NIH Pub No. 97–4216; 2000. Available at: https://www.nidcd.nih.gov/sites/default/files/Content%20Images/otitismedia.pdf . Accessed June 13, 2020. ; Hall MJ, Schwartzman A, Zhang J, Liu X. Ambulatory Surgery Data from Hospitals and Ambulatory Surgery Centers: United States 2010. National Health Statistics Reports; no 102. Hyattsville, MD: National Center for Health Statistics; 2017. ; E11 (R1) addendum: clinical investigation of medicinal products in the pediatric population; 2018. Available at: https://www.fda.gov/media/101398/download . Accessed June 13, 2020. ; Saunders JC, Kaltenbach JA, Relkin EM. Romand R. 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Pharmacokinetics of Single Dose Lidocaine and Epinephrine Following Iontophoresis of the Tympanic Membrane in a Double-Blinded Randomized Trial.