NCT00747669暂停4 期
A Pharmacokinetic Study of Synera™ (Lidocaine 70 mg and Tetracaine 70 mg Topical Patch) to Evaluate the Systemic Exposure to Lidocaine and Tetracaine in Neonates and Infants
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Evaluate the systemic exposure to lidocaine and tetracaine following application of Synera
研究概览
简要总结
This study will measure the amount of lidocaine and tetracaine in the blood after a 30 minute application of Synera.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- — 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be an infant of 1 to 4 months of age and weigh at least 2.5 kg or a neonate of 0 to 4 weeks postnatal age with a gestation period of at least 37 weeks, and weigh at least 1.8 kg.
- •Subject is scheduled to have a medically indicated minor superficial procedure for which topical local anesthesia would provide a benefit.
- •Subject has or will have an indwelling vascular access catheter for blood sampling at the time of the procedure visit. The indwelling vascular access catheter placement must be necessary for medical reasons other than the purposes of this study.
- •The additional blood draws for the purposes of this study do not pose more than a minor risk to the health and welfare of the subject.
排除标准
- •Subject has known allergies or sensitivities to any component of Synera.
- •Subject has clinically significant laboratory abnormalities.
- •Subject has known multiple allergies that could indicate hypersensitive skin.
- •Subject has known active atopic dermatitis at or near the patch application site.
结局指标
主要结局
Evaluate the systemic exposure to lidocaine and tetracaine following application of Synera
时间窗: 30 hours
次要结局
- Monitor the nature and frequency of adverse events(30 Hours)
研究者
研究点 (2)
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