NCT00539110已完成2 期
Differential Effects of Zolpidem Versus Ramelteon on Nocturnal Sleep in Pediatric Burn Patients: A Prospective, Randomized Crossover Trial With Polysomnographic Recordings
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Polysomnography Data
研究概览
简要总结
To examine sleep changes following therapeutic drug interventions designed to promote sleep.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Burn injury > 20% total body surface area
- •Between 3 and 18 years of age
- •< 7 days from acute injury
- •Written informed consent and HIPPA release signed
排除标准
- •Suspected anoxic brain injury or head injury
- •Hepatic or endocrine disease
- •History of alcoholism or substance abuse
- •Pre-existing neurological or primary psychiatric disorder
- •Medical history of pre-existing sleep disorder or lactose deficiency
- •Questionable survival (<72 hrs) as decided by PI
- •Receipt of drugs with known effects on sleep within 24 hrs of study entry
- •No informed consent/HIPPA release
研究组 & 干预措施
zolpidem
Experimental
zolpidem or ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization
干预措施: zolipidem (Drug)
ramelteon
Active Comparator
ramelteon or zolpidem dosed at 2200 and 0200 per the feeding tube depending on randomization
干预措施: ramelteon (Drug)
结局指标
主要结局
Polysomnography Data
时间窗: 2 weeks postburn
Determine if intervention product elicits more total sleep time
次要结局
- Pharmacokinetics(2 weeks postburn)
研究者
Michele Gottschlich
Director, Nutrition Services
Shriners Hospitals for Children
研究点 (1)
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