The Pharmacokinetics of 4% Lidocaine Gel When Applied Topically to the Breasts
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Pharmacokinetic Parameters Based on Plasma Concentration of Lidocaine and MEGX in Nanograms/Milliliter.
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •35 years and older
- •intact skin on breasts and chest wall
排除标准
- •sensitivity or allergy to lidocaine
- •liver or kidney dysfunction
- •breast feeding
- •currently smoke or chew tobacco
- •used lidocaine products within 48 hours of baseline lab, EKG, or gel application
- •exhibit neurological or cardiac signs or symptoms prior to gel application
- •are taking antiarrythmic medications, ciprofloxacin, erythromycin products, or oral contraceptives
- •history of Wolffe-Parkinson-White Syndrome (WPW) or congestive heart failure
- •heart rate below 60 or above 100 beats per minute
- •systolic blood pressure below 95 or above 180 mm Hg
- •PR interval greater 200 msec, QRS duration greater than 120 msec, QTc greater than 450 msec, or evidence of WPW on EKG
- •have an automatic implantable cardioverter defibrillator (AICD) or cardiac pacemaker
- •have had cancer, surgery, trauma, or myocardial infarction in the past 6 months
研究组 & 干预措施
lidocaine gel
干预措施: 4% lidocaine gel (Drug)
结局指标
主要结局
Pharmacokinetic Parameters Based on Plasma Concentration of Lidocaine and MEGX in Nanograms/Milliliter.
时间窗: Prior to gel application, and at 30 min, 60 min, and 2, 3, 4, 6, and 8 hours after
Plasma concentration of lidocaine and MEGX in nanograms/milliliter were measured prior to one-time application of 4% lidocaine gel on the skin of the breasts and chest wall as recommended for use as as pre-medication to reduce discomfort during screening mammography, and at 30 minutes, 60 minutes, and 2, 3, 4, 6, and 8 hours. Due to the high frequency of nondetectable values, pharmacokinetic parameters could not be estimated. Measurements at all time points were grouped together to select a median.
次要结局
- EKG Changes(Prior to gel application and 3 hours after)
- Variation of Heart Rate (Bpm), Respiratory Rate (Respirations Per Minute, Rpm), Systolic Blood Pressure (mm Hg), and Diastolic Blood Pressure (mm Hg) Over Time.(Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after)
- Frequencies of Moderate, Severe, or Life-threatening Side Effects(Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after)