Effect of Synera in Reducing Pain Associated With Venipuncture and Superficial Dermatologic Procedures
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Percentage of Patients With No or Minor Pain (VAS<3)
研究概览
简要总结
Synera, which is a heated topical patch containing both lidocaine and tetracaine, is intended to reduce the pain associated with venipuncture and superficial dermatologic procedures by numbing the skin. This study will test the effectiveness of the Synera lidocaine/tetracaine patch when administered for 30 ± 5 minutes to provide dermal anesthesia in adult oncology patients undergoing venipuncture as part of their care, for treatment or diagnostics (laboratory or imaging). Compared to the use of the placebo patch, this study hypothesizes that the difference of 1 cm on the 0-10 visual analogue scale (VAS) will be observed 30 minutes after the use of the Synera patch. Pain intensity will be assessed by a 0-10 VAS
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with any tumor type where treatment is received through venipuncture or any procedure that is needle based or who require regular pharmacokinetic (PK) study.
- •Is 18 years of age or older.
- •Patients expected to undergo the first venipuncture procedure within 5 working days of enrollment.
- •Male or female patients
- •Has signed the most recent Patient Informed Consent Form
- •Has signed a Patient Authorization Form (HIPPA)
排除标准
- •Patients with sensitivity to lidocaine, tetracaine, or any other component of the product
- •Known sensitivity to any components of test materials (sulphites and adhesives)
- •Patients with damaged or broken skin at the designated patch site
- •Pregnant or breastfeeding women patients
- •Use of any immediate-release single-agent opioid product (ie, morphine, oxycodone, hydrocodone, hydromorphone, oxymorphone, or tramadol) or combination products containing acetaminophen or ibuprofen with one of these agents within 4 hours of the patient's visit
- •Previous irradiation to the site of the patch
研究组 & 干预措施
Arm 1
First application: Synera (lidocaine 70mg/tetracaine 70mg) patch; Second application: Placebo patch
干预措施: Synera (lidocaine 70mg/tetracaine 70mg) (Drug)
Arm 2
First application: Placebo patch; Second application: Synera (lidocaine 70mg/tetracaine 70mg) patch
干预措施: Synera (lidocaine 70mg/tetracaine 70mg) (Drug)
结局指标
主要结局
Percentage of Patients With No or Minor Pain (VAS<3)
时间窗: 30 minutes after the venipuncture.
The primary efficacy endpoint is the subject's report of pain intensity regarding the venipuncture using a 0-10 VAS. The VAS \<3 is considered as patients with no or minor pain and would be compared between 2 groups.
Percentage of Patients With No Pain (VAS=0)
时间窗: 30 minutes after the venipuncture.
The primary efficacy endpoint is the subject's report of pain intensity regarding the venipuncture using a 0-10 VAS. The VAS =0 is considered as patients with no pain and would also be compared between 2 groups.
次要结局
- Global Assessment of Satisfaction With Venipuncture(30 minutes after the venipuncture.)