In Children, Placing a Synera Patch for Intravenous Access Combined With Administration of a Propofol-Lidocaine Mixture Decreases Pain Associated With Propofol Intravenous Injection.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Number of Children in Each Group Who Don't Feel Pain or Have Mild Pain on Propofol Injection.
研究概览
简要总结
The main objective is to evaluate if combining placing the Synera patch and using Propofol /Lidocaine mixture will further decrease the pain associated with the IV injection of Propofol.
详细描述
Commonly, anesthesiologists inject Propofol, a sleeping medication, intravenously to induce general anesthesia.Propofol injection is commonly associated with burning pain. In a previous onsite study we concluded that placing a Synera patch at least 30 minutes before placing the IV decreased the pain associated with the Propofol injection. Also,a study documented that adding Lidocaine to the Propofol decreases the pain associated with propofol injection. In our study here we are trying to evaluate if combining the use of both the Synera patch and the Propofol-Lidocaine mixture will further decrease the pain associated with the IV Propofol injection.
All children will receive a Synera Patch, it will be placed on the dorsum of both hands for at least 30 minutes.All Children will be Sedated with P.O Versed.
22 g IV will be started either in the holding area or in the OR. Children will be randomized into groups using a computer generated randomization list:- Group 1 will receive Propofol -Lidocaine mixture. Group 2 will receive Propofol-Saline mixture. An independent blinded observer and an anesthesia member will independently evaluate pain on Propofol injection according to pain scale.
- No pain.
- Mild Pain (associated with facial expression of pain).
- Moderate Pain(Pulling the arm).
- Severe Pain (screaming).
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, 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
- 是
入选标准
- •Healthy Children 6-17 yrs.
- •Scheduled to receive general anesthesia for an elective procedure.
- •ASA classification 1-2
排除标准
- •Children with Skin disease and/or Skin infections.
- •Allergy to Propofol, Lidocaine or tetracaine.
研究组 & 干预措施
Propofol-Lidocaine mixture
All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.
干预措施: Lidocaine/tetracaine transdermal patch (Device)
Propofol-Lidocaine mixture
All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.
干预措施: Lidocaine (Drug)
Propofol -Saline mixture
All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.
干预措施: Lidocaine/tetracaine transdermal patch (Device)
Propofol -Saline mixture
All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.
干预措施: Saline (Drug)
结局指标
主要结局
Number of Children in Each Group Who Don't Feel Pain or Have Mild Pain on Propofol Injection.
时间窗: During propofol injection.
次要结局
- Pain Intensity(During Propofol injection.)
研究者
Samia Khalil
Professor Of Pediatric Anesthesia
The University of Texas Health Science Center, Houston