In Children, Does the Use of Synera Patch for Local Analgesia Before Vascular Access Reduce Pain Associated With Propofol Injection for Anesthesia Induction?
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of children in each group who do not feel pain or have mild pain on propofol injection.
研究概览
简要总结
The purpose of this study is to evaluate if the Synera Patch (lidocaine/tetracaine patch), used to numb the skin before IV placement, is effective in reducing pain associated with propofol IV administration when inducing general anesthesia, compared to Gebauer's Ethyl Chloride topical anesthetic skin refrigerant.
详细描述
Commonly, anesthesiologists inject Propofol, a sleeping medication, intravenously to induce general anesthesia. Propofol injection is associated with pain that can be severe.
The investigators also place a lidocaine/tetracaine skin patch (Synera) to decrease pain associated with IV placement. Because the local anesthetics of the Synera patch diffuse deep underneath the skin, in this study the investigators would like to evaluate whether the application of Synera Patch can decrease the pain associated with propofol injection.
Children will be randomized to receive either the patch or the Ethyl Chloride before the IV placement. A total of 33 patients will be enrolled in each group.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy, outpatient children, 6-17 years old
- •American Society of Anesthesiologist Physical Classification rating of 1 or 2
- •Elective procedure requiring general anesthesia at Memorial Herman Hospital, The Medical Center, Houston, Texas
排除标准
- •Skin disease or infection (on dorsum of hands)
- •Allergy to lidocaine or tetracaine
研究组 & 干预措施
ethyl chloride vapocoolant spray
Half of the patients will randomly be assigned to receive Gebauer's ethyl choride topical anesthetic vapo-coolant spray immediately prior to placing a 22 gauge intravenous catheter.
Pain in this group will be evaluated at the time of IV placement by an independent observer (unblinded) and the patient on a 0-10 scale. Pain will again be evaluated when propofol is injected at anesthesia induction by a blinded observer and the staff anesthesiologist (also blinded) on a scale of 1-4.
Blinding will occur following IV placement by draping and securing the hand and IV site with Coban self-adherent elastic wrap to cover any skin changes due to the ethyl chloride or the patch.
干预措施: Gebauer's Ethyl Chloride (Drug)
Synera Patch
The other half of the patients will randomly be assigned to receive Synera Patches, to be applied to the dorsum of both hands, at least 30 minutes before placing a 22 gauge intravenous catheter.
Pain in this group will be evaluated at the time of IV placement by an independent observer (unblinded) and the patient on a 0-10 scale. Pain will again be evaluated when propofol is injected at anesthesia induction by a blinded observer and the staff anesthesiologist (also blinded) on a scale of 1-4.
Blinding will occur following IV placement by draping and securing the hand and IV site with Coban self-adherent elastic wrap to cover any skin changes due to the patch or ethyl chloride.
干预措施: lidocaine/tetracaine transdermal patch (NDC 43469-864-01) (Device)
结局指标
主要结局
Number of children in each group who do not feel pain or have mild pain on propofol injection.
时间窗: Within one hour, plus or minus one half hour
The primary outcome variable is the success/failure of therapy. The therapy is considered a success if a child feels no pain OR has mild pain.
次要结局
- Pain intensity(Within one hour, plus or minus one half hour)
研究者
Samia Khalil
Professor of Pediatric Anesthesia
The University of Texas Health Science Center, Houston