Evaluation of a Standardized Low-Dose Bolus Ketamine Pathway for Management of Pediatric Sickle Cell Patients Presenting to the Emergency Department With Pain
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Hospital admission rates after using a Ketamine first pathway as compared to after the use of Opioids.
研究概览
简要总结
The goal of this study is to learn if Ketamine works more efficiently, as compared to Opioids, for Sickle Cell Pain The main questions it aims to answer are:
Does Ketamine lower the number of times participants need to be admitted for continued pain control during a Sickle Cell Pain Crisis.
Does Ketamine decrease the amount of time it takes to reach adequate pain control/pain score improvement, as compared to Opioids.
Patients could have too low or too high blood pressure or sleepiness. Researchers will compare Ketamine to Opioids (Morphine or Dilaudid) to see if Ketamine works to treat pain enough that you do not need to be admitted to the hospital.
Participants will:
On arrival to the Children's ER for Sickle Cell Pain crisis will get Ketamine, instead of Morphine or Dilaudid, along with the typical Tylenol, Toradol, Lidocaine patch for pain control while in the ER.
During this time we will follow your reported pain scale (0-10) to monitor your pain response to the Ketamine, as well as follow rate of hospital admission.
详细描述
In this study, we will be using Ketamine for pain control during a Sickle Cell Disease pain crisis, along with our current adjuncts (Tylenol, Toradol, Lidocaine patch, or heat packs), in hopes to lower the rate of admission to the hospital for continued pain control.
When presenting to the ER for pain crisis the first dose of Ketamine should be given within 30 minutes of arrival to the ER. Prior to giving Ketamine, vitals and current pain scale will be recorded in the chart. The vitals and pain scale will be rechecked every 30 minutes and documented in the chart. If a second or third dose is needed at the one-hour mark, then a second dose will be given. If after the second dose the patient does not report sufficient pain control then a third dose will be given and the patient will be admitted to the hospital.
The patient is free to opt out of the Ketamine pathway at any time and Opioids can be administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed Sickle Cell Disease (any genotype), Presenting to the Emergency Department with Vaso-occlusive crisis/pain crisis, Consent obtained
排除标准
- •Ketamine allergy, Severe agitation/psychosis, Pregnancy, Hemodynamic instability (as judged by physician), Increased intracranial pressure, Severe hepatic impairment, Ketamine use within the previous 24 hours, Presentation for non-VOC-related pain (i.e. fever, acute chest syndrome, stroke, traumatic injuries etc).
结局指标
主要结局
Hospital admission rates after using a Ketamine first pathway as compared to after the use of Opioids.
时间窗: From time of patient enrollment and IRB approval for 36 months
次要结局
- Emergency Department length of stay after using the Ketamine first pathway.(From time of patient enrollment and IRB approval until 36 months.)
- Pain score reduction in the acute setting after using a Ketamine first pathway as compared to Opioid first pathway.(From time of patient enrollment and IRB approval until 36 months.)
- Rate of repeat visits to the Emergency Department within 72 hours for pain after a Ketamine first pathway was followed.(From time of patient enrollment and IRB approval until 36 months.)
- Inpatient length of stay (in number of days) for to reach adequate length of stay.(From time of patient enrollment and IRB approval until 36 months)
- Adverse events experienced after using a Ketamine first pathway(From time of patient enrollment and IRB approval until 36 months.)
研究者
Cynthia Karlson
Professor, Vice-Chair for Pediatric Research
University of Mississippi Medical Center