Ashburn M A, Gauthier M, Love G, Basta S, Gaylord B, Kessler K
Department of Anesthesiology, University of Utah Health Sciences Center, Salt Lake City, USA.
Clin J Pain. 1997 Mar;13(1):22-6. doi: 10.1097/00002508-199703000-00005.
The primary objective was to evaluate the clinical safety and effectiveness of the iontophoretic administration of lidocaine HCl 2% and epinephrine 1:100,000 to induce local dermal anesthesia before intravenous (i.v.) cannulation.
Section I: Open, nonblinded. Section II: Randomized, double-blind, placebo-controlled.
Section I: Healthy adult volunteers. Section II: Patients presenting for scheduled outpatient eye surgery.
Section I: Seven healthy adult volunteers. Section II: Forty-four patients requiring i.v. cannulation before scheduled eye surgery.
Section I: Volunteers received iontophoresis of lidocaine HCl 2% with epinephrine 1:100,000 for a total delivery current of 40 mA min. Section II: Patients received iontophoresis for a total delivery current of 40 mA min of lidocaine HCl 2% with epinephrine 1:100,000 (active) or saline (control) immediately before intravenous cannulation with a 20-gauge i.v. catheter.
Section I: Venous blood plasma lidocaine levels, adverse events associated with iontophoresis. Section II: Patient and investigator assessment of analgesia, patient acceptance of iontophoresis, adverse events associated with iontophoresis.
Section I: No detectable levels of lidocaine were identified in any blood plasma sample. Adverse effects were minimal and transitory. Section II: Pain was decreased following lidocaine iontophoresis in comparison with controls, as determined by the patients and investigators. Iontophoresis was well accepted by the patients. Adverse effects were minimal and transitory.
Iontophoresis of lidocaine 2% with 1:100,000 epinephrine for short delivery times does not lead to delivery of clinically important systemic levels of lidocaine in healthy adults. Iontophoresis of lidocaine 2% with 1:100,000 epinephrine provides adequate skin anesthesia for placement of peripheral small-gauge i.v. catheters.
主要目的是评估在静脉(i.v.)插管前,通过离子导入法给予2%盐酸利多卡因和1:100,000肾上腺素以诱导局部皮肤麻醉的临床安全性和有效性。
第一部分:开放、非盲法。第二部分:随机、双盲、安慰剂对照。
第一部分:健康成年志愿者。第二部分:计划进行门诊眼科手术的患者。
第一部分:7名健康成年志愿者。第二部分:44名计划进行眼科手术前需要静脉插管的患者。
第一部分:志愿者接受2%盐酸利多卡因与1:100,000肾上腺素的离子导入,总输送电流为40 mA·min。第二部分:患者在使用20号静脉导管进行静脉插管前,立即接受40 mA·min的2%盐酸利多卡因与1:100,000肾上腺素(活性药物)或生理盐水(对照)的离子导入。
第一部分:静脉血浆利多卡因水平,与离子导入相关的不良事件。第二部分:患者和研究者对镇痛的评估,患者对离子导入的接受程度,与离子导入相关的不良事件。
第一部分:在任何血浆样本中均未检测到可检测水平的利多卡因。不良反应轻微且短暂。第二部分:与对照组相比,利多卡因离子导入后疼痛减轻,这由患者和研究者确定。离子导入被患者很好地接受。不良反应轻微且短暂。
在健康成年人中,短时间给予2%利多卡因与1:100,000肾上腺素的离子导入不会导致临床上重要的全身水平的利多卡因输送。2%利多卡因与1:100,000肾上腺素的离子导入可为外周小口径静脉导管的放置提供足够的皮肤麻醉。