A Randomized Comparison of the Buzzy® Personal Pain Relief Device to Intravenous Lidocaine for Controlling Injection Pain During Intravenous Propofol Induction of Anesthesia in Children
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Non-inferiority of Buzzy pain relief device as compared to intravenous lidocaine at preventing pain on injection of propofol
研究概览
简要总结
Propofol is a drug commonly used for induction of general anesthesia in children as well as adults; however, propofol can cause pain on injection, possibly more frequently in children. One common method of preventing propofol injection pain is the injection of lidocaine just prior to the injection of propofol through an intravenous catheter. This practice is sometimes, but not universally, effective, and involves exposure of patients to an additional drug. Our proposal is to use a non-pharmacologic adjunct in an attempt to attenuate the pain of propofol injection. The Buzzy® personal pain relief device is an FDA-approved product that provides non-pharmacologic relief of pain from minor painful procedures in children. The investigators propose the non-invasive Buzzy® personal pain relief device might prove just as effective at relieving the pain of propofol injection as the injection of intravenous lidocaine just prior to propofol injection. Randomized groups and a blinded observer will be used in this study of 106 children, with one group of patients receiving a current standard of care for reduction of the pain of propofol injection, that is, lidocaine prior to propofol, and one group receiving the placement of the Buzzy® device above the injection site prior to injection of propofol to reduce the pain of propofol injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are in the American Society of Anesthesiologists with physical status classification I to III (meaning healthy patients, patients with mild systemic disease, and patients with serious controlled systemic disease)
- •Between the ages of 12 and 17
- •Presenting from home for procedures including, but not limited to, upper and lower endoscopy, orthopedic surgery, and medical imaging.
排除标准
- •Patients requiring a rapid sequence induction of anesthesia and patients requiring an emergency procedure
- •Patients requiring mask induction for anesthesia
研究组 & 干预措施
Buzzy device
Use of the Buzzy device during propofol induction in an attempt to alleviate propofol injection pain
干预措施: Buzzy device (Device)
Intravenous lidocaine
Use of intravenous lidocaine during propofol induction in an attempt to alleviate propofol injection pain
干预措施: Intravenous lidocaine (Drug)
结局指标
主要结局
Non-inferiority of Buzzy pain relief device as compared to intravenous lidocaine at preventing pain on injection of propofol
时间窗: Every minute starting 1 minute prior to induction of anesthesia, during induction, and after induction of anesthesia for a total of ten minutes
Two scales will be used by the observer to rate the amount of pain, if any, on propofol injection, the FLACC (face, legs, activity, cry, consolability) Scale and the Cameron Four Point Scale for Pain on Propofol Injection. The FLACC Scale is a 0-10 scale where the observer rates pain based on facial expression, movement of the body and legs, vocalization, and reassurability. The Cameron Scale was developed by researchers to specifically rate the pain of propofol injection for a previous study, and uses the presence or absence of grimace, cry, and withdrawal to rate pain on a 0-3 scale. Both scales are being used because the FLACC Scale was not specifically designed for propofol pain, and has some limitations in its application for this purpose; however, the Cameron Scale is limited by its narrow application of three types of expressions of pain.
次要结局
- Vital Signs(Every minute starting 1 minute prior to induction of anesthesia, during induction, and after induction of anesthesia for a total of ten minutes)