Tusker Medical, Inc., a subsidiary of Smith + Nephew, Menlo Park, California.
Ear Medical Group.
Otol Neurotol. 2021 Aug 1;42(7):1095-1103. doi: 10.1097/MAO.0000000000003128.
To evaluate local and systemic safety of bilateral iontophoretic administration of lidocaine with epinephrine or lidocaine alone to the tympanic membrane (TM).
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.
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.
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.
评估双侧离子导入利多卡因联合肾上腺素或单独利多卡因至鼓膜（TM）的局部和全身安全性。
在一个单中心进行了一项随机、双盲、双臂研究。将健康成年人随机分为双侧离子导入治疗 2%利多卡因、1:100000 肾上腺素或 2%利多卡因（对照）。在治疗前和治疗后 3 天进行耳镜检查、颅神经检查、鼓室压图和听力计安全评估。通过分析离子导入前后 120 分钟内的生命体征以及离子导入前后 230 分钟内的血液样本，评估全身安全性。
25 名受试者接受了双侧离子导入利多卡因和肾上腺素（n=15 名受试者）或单独利多卡因（n=10 名受试者）治疗。两组的平均血浆肾上腺素浓度均在内源性肾上腺素的正常范围内。两组的平均血浆利多卡因浓度无统计学差异，从给予利多卡因加肾上腺素（离子导入后即刻至 230 分钟）后 0.245 至 2.28ng/ml 不等，与给予单独利多卡因后 1.35 至 2.14ng/ml 不等。肾上腺素的存在减缓了利多卡因的全身吸收。利多卡因水平（Cmax 2.24ng/ml）大约比轻微利多卡因毒性的阈值低 2000 倍。未报告与设备、程序或药物相关的不良事件。
通过药物的低血浆水平和无严重或非严重的设备、程序或药物相关不良事件，证明了双侧离子导入 2%利多卡因、1:100000 肾上腺素至 TM 的局部和全身安全性。
