Early Low-dose Ketamine Infusion Versus Usual Care for Sickle Cell Pain Crisis: a Randomized, Prospective Study.
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Percentage reduction in grand mean opioid consumption from 0 to 72 hours
研究概览
简要总结
The purpose of this study is to prospectively study the efficacy of low dose ketamine infusions in treating patients who are admitted to the hospital with a sickle cell pain crisis. Participants will be prospectively randomized in unblinded fashion in the first 12 to 24 hours of an inpatient admission for sickle cell pain crisis to receive pain management without ketamine infusion (Group A) versus pain management that includes low-dose ketamine infusion starting at 0.2mg/kg/h (Group B). The effect of this intervention on various pain management and healthcare utilization outcome measures will be recorded and analyzed to determine whether or not there is a measurable benefit of using ketamine infusions in this patient 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a pre-existing/known diagnosis of sickle cell disease, prior to the current presentation
- •Admitted to Duke University Hospital with a clinical diagnosis of sickle cell crisis
- •Are at least 18 years old at time of admission
- •Have been admitted to any hospital for sickle cell pain crisis at least twice in the last year
- •Have documented severe pain at time of admission, requiring intravenous opiates
- •Must be able to speak English
排除标准
- •Are greater than 70 years old at time of admission
- •Carry a diagnosis of cirrhosis, elevated intracranial pressure, elevated intraocular pressure, active coronary artery disease, and psychiatric disorders with history of psychosis
- •Are pregnant or breastfeeding
- •Are concomitantly admitted for another medical or surgical problem in addition to sickle cell pain crisis
- •Have been admitted to any hospital for a sickle cell pain crisis greater than 10 times in the last year
- •Were admitted to any hospital for sickle cell pain crisis within the last 30 days
- •Are able to fully and properly consent for their own medical care, with no restrictions or limitations
研究组 & 干预措施
Pain management without ketamine infusion
Pain management without ketamine infusion. No other restrictions on pain management or medications.
干预措施: Pain management (Other)
Pain management with ketamine infusion
Pain management that includes a ketamine infusion. No other restrictions on pain management or medications.
干预措施: Ketamine (Drug)
Pain management with ketamine infusion
Pain management that includes a ketamine infusion. No other restrictions on pain management or medications.
干预措施: Pain management (Other)
结局指标
主要结局
Percentage reduction in grand mean opioid consumption from 0 to 72 hours
时间窗: baseline, 72 hours
次要结局
- Time from inpatient admission to readiness for discharge(Upon discharge from the hospital (an average of 1 week))
- Percentage reduction in grand mean pain score using the 11-point visual analog scale(baseline, 72 hours)
- 30-day hospital readmission rate(30 days from discharge)