Low Dose Ketamine to Enhance VR Analgesia During Painful Burn Care Procedure.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Graphic Rating Scale (GRS) is a questionnaire consists of three subjective pain ratings, one subjective anxiety rating, and one rating of fun using the 0-10.
研究概览
简要总结
The purpose of the research is to see whether a low dose of ketamine, a medication used to reduce pain, enhances the effectiveness of a virtual reality video game, which is used as a form of distraction from pain during a painful burn care procedure.
详细描述
This study is conducted in a hospital setting. It is a randomized controlled trial comparing the use of virtual reality distraction (VRD) and standard pain medications to the use of VRD, standard pain medications and a single low dose of ketamine as a means to reduce pain during a painful procedure in patients in the hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18 years
- •Compliant and able to complete questionnaires
- •No history of psychiatric disorder
- •Not demonstrating delirium, psychosis or any form of Organic Brain Disorder
- •Able to communicate verbally
- •English-speaking
- •IV access already in place
排除标准
- •Age less than 18 years
- •Not capable of indicating pain intensity
- •Not capable of filling out study measures
- •Evidence of traumatic brain injury
- •History of psychiatric disorder
- •Demonstrating delirium, psychosis or any form of Organic Brain Disorder and associated memory problems
- •Unable to communicate orally
- •Receiving prophylaxis for alcohol or drug withdrawal
- •Developmental disability
- •Any face/head/neck injuries that interfere with the use of Virtual Reality equipment
- •Non-English Speaking
- •Extreme susceptibility to motion sickness
- •Seizure history
- •No IV access already in place
研究组 & 干预措施
VR durin burn care without Ketamine
Comparing virtual reality during burn care without Ketamine.
干预措施: Virtual Reality (Behavioral)
VR during burn care with Ketamine
Comparing Virtual Reality during burn care with Ketamine
干预措施: Virtual Reality (Behavioral)
结局指标
主要结局
Graphic Rating Scale (GRS) is a questionnaire consists of three subjective pain ratings, one subjective anxiety rating, and one rating of fun using the 0-10.
时间窗: 1 day (Immediately following burn care )
次要结局
未报告次要终点
研究者
David R. Patterson
PhD. ABPP, Professor
National Institute of General Medical Sciences (NIGMS)