Efficacy of Quetiapine for Pediatric Delirium
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Time to First Resolution of Delirium
研究概览
简要总结
This study is designed to assess the safety and efficacy of quetiapine as treatment for pediatric delirium.
详细描述
Many children in the ICU become confused, due to their underlying illness or treatment effects. The medical term for this confusion is delirium. In adults, a medication called quetiapine has been effective in treating delirium. This is considered an "off label" use as the FDA has not approved quetiapine for this indication.
Pediatricians have been using quetiapine to treat delirium in children as well, but there is currently no data proving that it is effective in children. This study is being done to determine if quetiapine is effective for the treatment of ICU delirium in children.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient in the PICU aged 1 year to 21 years old who is diagnosed with delirium
排除标准
- •Richmond Agitation Sedation Scale (RASS) score of -4 or -5 (deeply sedated or unarousable).
- •current treatment for alcohol withdrawal
- •hepatic encephalopathy
- •pregnancy
- •diagnosis of major depressive disorder or bipolar disorder
- •diagnosis of movement disorder
- •diagnosis of diabetic ketoacidosis
- •baseline QTc >500 milliseconds
- •non-English speaking subjects and/or parent/guardian
研究组 & 干预措施
Quetiapine
A randomized group will receive quetiapine as treatment for delirium.
干预措施: quetiapine (Drug)
Placebo
A randomized group will receive placebo, and not quetiapine.
干预措施: Placebo (Other)
结局指标
主要结局
Time to First Resolution of Delirium
时间窗: Within the first 10 days after study enrollment
Participants were screened for delirium daily. This describes the number of days from study drug initiation (either quetiapine or placebo) to first resolution of delirium (defined as a score of less than 9 on teh Cornell Assessment of Pediatric Delirium \[CAPD\]). If delirium did not resolve within the 10 day period, this defaults to 10 days.
次要结局
- Total ICU Days With Delirium(Within 10 days after study enrollment)