Exploring the Safety and Efficacy of Low-dose Ketamine Infusions for Pain Control in Acute Burn Injury
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in pain severity
研究概览
简要总结
The purpose of this study is to identify the optimal dosing strategy for low-dose ketamine infusions in adult acute burn injury patients when used with usual pain medications.
详细描述
This Aim will identify the safest and most optimal dosing strategy for low-dose ketamine infusions. While the hourly rate for low-dose ketamine infusions used for adjunctive analgesia appears to be well-established both in the medical literature and our institutional protocols, there is no information available for this specific population of patients (adult acute burn injury) to know whether the infusions should be utilized for discrete periods of time or should be given continuously. Findings from this study will help provide preliminary data on the optimal dosing strategy of this medication for adjunctive analgesia in this population.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute burn injury comprising 10-30% of total body surface. Burns severity may include second or third degree burns
- •Burn injury must have occurred within 72 hours of enrollment and randomization
- •Subjects may be opioid-naïve or opioid non-naïve
- •Anticipated stay in the burn unit is greater than 4 days, which is typically the minimum length of stay for patients with this level of burn injury
排除标准
- •Burn injury older than 72 hours
- •Acute burn injury comprising >30% total body surface
- •Patients who are intubated
- •Patients who have contraindication to ketamine administration
研究组 & 干预措施
Group 2: Continuous
Continuous ketamine infusions (24 hours/day). Duration of participation will last 4 days.
干预措施: Opioids (Drug)
Group 1: Daily
Daily ketamine infusions of 5 hours in length. Duration of participation will last 4 days.
干预措施: Ketamine (Drug)
Group 1: Daily
Daily ketamine infusions of 5 hours in length. Duration of participation will last 4 days.
干预措施: Opioids (Drug)
Group 2: Continuous
Continuous ketamine infusions (24 hours/day). Duration of participation will last 4 days.
干预措施: Ketamine (Drug)
结局指标
主要结局
Change in pain severity
时间窗: Day 4
Pain severity measured using the 11-point Visual Numerical Scale (VNS). Scores range from 0 to 10. A score of 0 represents no pain. A score of 10 represents the worst pain imaginable. The score will be collected each day. An average of the score will be calculated for all days of the study.
次要结局
- Opioid Analgesic Consumption(Day 4)
- Side effects / Adverse effects(Days 1-4)