ISRCTN02639863已完成未知
SLEEPS: Safety profiLe, Efficacy and Equivalence in Paediatric intensive care Sedation
nited Bristol Healthcare NHS Trust (UK)0 个研究点目标入组 1,000 人开始时间: 2007年1月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 09/05/2008:
- •1. Children aged 30 days (37 weeks gestation or greater) to 15 years inclusive
- •2. Admitted to Paedatric Intensive Care Unit (PICU) and likely to require intubation and ventilation for more than 48 hours
- •3. Recruitment within 48 hours of arrival in PICU
- •4. Adequately sedated: COMFORT score within the range of greater than or equal to 17 and less than or equal to 26
- •5. Fully informed written proxy consent
- •Previous inclusion criteria:
- •1. Children aged 30 days to 16 years
- •2. Admitted to PICU and likely to require intubation and ventilation for more than 48 hours
- •3. Recruitment within 48 hours of arrival in PIC
排除标准
- •Current exclusion criteria as of 09/05/2008:
- •1. Those patients with open chests following cardiac surgery
- •2. Those patients chronically treated for raised blood pressure
- •3. Current treatment with beta blockers
- •4. Acute traumatic brain injury
- •5. Those patients requiring haemodialysis
- •6. Those patients requiring ECMO treatment
- •7. Those patients with severe neuromuscular problems/impairment
- •8. Known allergy to either of the trial medications (clonidine, midazolam or morphine)
- •9. Current treatment with continuous or intermittent muscle relaxants
- •10. Those patients known to be pregnant
- •11. Currently participating in a conflicting clinical study or participation in a clinical study involving a medicinal product in the last three months
- •Previous exclusion criteria:
- •1. Those patients with open chests following cardiac surgery
- •2. Those patients chronically treated for raised blood pressure
- •3. Current treatment with beta blockers
- •4. Acute traumatic brain injury
- •5. Known allergy to either of the trial medications (clonidine, midazolam or morphine)
- •6. Current treatment with continuous or intermittent muscle relaxants
研究者
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