Cardiovascular Safety of Dexmedetomidine in Pediatric Burn Patients.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Percent Change in Mean Arterial Pressure (MAP)
研究概览
简要总结
Dexmedetomidine is a sedative drug approved for adult patients, intubated, in intensive care units. We are studying whether this drug is cardiovascularly safe in pediatric patients who have recently been burned.
详细描述
This is an ascending dose study evaluating the cardiovascular safety of dexmedetomidine bolus/infusions in acutely burned pediatric patients. The study entails a bolus of dexmedetomidine, followed by 2 hours of increasing infusion doses. Cardiovascular parameters including EKG, heart rate, oxygen saturation, blood pressure, are recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pediatric patient
- •>25% total body surface area (tbsa) burn and < 90% tbsa
- •opioid requirements > 0.1 mg/kg/hour of morphine (or equivalent)
- •midazolam requirement > 0.1 mg/kg/hour
- •treatment team determined that patient should be started on dexmedetomidine
排除标准
- •hemodynamically unstable patients (epinephrine > 1.0 ug/kg/min, levophed > 0.75 ug/kg/min, dopamine > 10 ug/kg/min)
- •pregnant patients
- •patients with history of heart block
- •patients with congenital heart disease
- •patients with significant hepatic dysfunction
- •patients with urine output < 0.5 ml/kg/hour [averaged] over past 24 hours
研究组 & 干预措施
Ascending dose study
Ascending doses of dexmedetomidine (as per protocol)
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Percent Change in Mean Arterial Pressure (MAP)
时间窗: 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration
Looking at hemodynamic response to dexmedetomidine. Mean arterial pressure primary outcome measure.
次要结局
- Presence of Arrhythmias.(10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration)
- Oxygen Saturation(10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration)
- Heart Rate(10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration)
研究者
Erik S. Shank, MD
Pediatric Anesthesiologist
Massachusetts General Hospital