Comparison of Lidocaine/Tetracaine Patch (SyneraTM), 4% Liposomal Lidocaine Cream (LMX-4) and Placebo for Pain Reduction During Venipuncture in Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Face Pain Scale-Revised (FPS-R)
研究概览
简要总结
The purpose of this study is to compare the effect of Synera patch versus LMX-4 cream and placebo on the level of pain, observed distress, difficulty of venipuncture and skin side effects in children undergoing intravenous blood draw in the emergency setting or the phlebotomy lab.
详细描述
This study will compare the effectiveness of a patch applied for 30 minutes (Synera-lidocaine 70 mg/tetracaine 70 mg) with the effectiveness of a cream (LMX-4- 4% liposomal lidocaine) and a placebo patch applied for the same length of time in reducing pain due to needle sticks in children. One hundred fifty children and adolescents 5-17 years old admitted to emergency department or presenting to the phlebotomy lab. will be randomly placed in each group. Children will rate their level of pain using the Faces Pain Scale-Revised (FPS-R) before the medication is applied, after the medication is removed and after the needle stick. Parents and research observer will fill out the Observed Behavioral Distress (OBD) score. The phlebotomist will rate how difficult it was to perform the needle sticks. Any skin reaction seen by the investigator after the cream or patch is removed will be noted and compared among the three groups.
Subjects will be monitored from the time of enrollment to 5 minutes post phlebotomy.The Time Frame for which data will be presented is one (1) year.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children requiring venipuncture for medical care
- •The ability to demonstrate proper understanding of the Faces Pain Scale-Revised (FPS-R)
- •Parents of enrolled children need to be present during the procedure and be willing to rate their child's pain
排除标准
- •Damaged or inflamed skin at the designated application site
- •Known sensitivity to components of Synera or LMX-4 (lidocaine, tetracaine, or local anesthetics of the amide or ester type, PABA derivatives)
- •Contraindications to Synera or LMX-4 use (severe hepatic disease, history of drug-induced methemoglobinemia, taking Class 1 antiarrhythmics)
- •Use of analgesics during the past 24 hours
- •Teenage female participants who are pregnant or lactating
- •If in the attending's judgment the patient cannot wait wait 30 minutes for a blood drawn. These conditions include but are not limited to: sepsis, trauma, surgical emergencies, severe dehydration.
研究组 & 干预措施
Synera Patch
Synera Patch (lidocaine 70 mg/ tetracaine 70 mg)
干预措施: Synera Patch (Drug)
LMX-4 Cream
LMX-4 (liposomal lidocaine 4%) cream
干预措施: LMX 4 Cream (Drug)
Placebo Patch
Placebo Patch
干预措施: Placebo Patch (Drug)
结局指标
主要结局
Face Pain Scale-Revised (FPS-R)
时间窗: Before the medication application, after the medication removal and after the venipuncture
The child's understanding of the FPS-R will be pretested. Using the scale, the child will rate the level of pain experienced before the medication (patch, cream) application, after the medication removal and after the venipuncture.
次要结局
- Draize Scale for Adverse Skin Reactions(After removal of the patch or Tegaderm)
- Observed Behavioral Distress Scale (OBDS)(Before, during and after venipuncture)
- Venipuncture Difficulty(After venipuncture)
研究者
Carol Morreale
Clinical Pharmacist Specialist
CAMC Health System