NCT00713726已完成3 期
Post-Operatory Analgesia in Newborn Infants: a Comparative Study of Fentanyl Versus Tramadol
Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2006年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Pain assessment wuth CRIES and NFCS pain scales during the first 72 hours after surgical procedure
研究概览
简要总结
In newborn infants submitted to surgical procedures, tramadol may provide an effective analgesia and decrease the time on mechanical ventilation support and the time to achieve full enteral feeding.
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
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant 0-28 days of life with indication of large or medium surgical procedure (definition according to the American College of Cardiology, American Heart Association - 2002)
排除标准
- •Death or hospital discharge until 72 hours after surgical procedure
- •New surgery until 72 hours after the studied surgical procedure
- •Proved bacterial infection before surgery
- •Ambiguous genitalia
- •Chromosomal syndromes
研究组 & 干预措施
F
Active Comparator
Patients that received continued infusion of fentanyl at a steady dose for the first 48 hours and, then, doses were gradually decreases until stop
干预措施: FentanyL (Drug)
T
Experimental
Patients that received continued infusion of tramadol at a steady dose for the first 48 hours and, then, doses were gradually decreases until stop
干预措施: Tramadol (Drug)
结局指标
主要结局
Pain assessment wuth CRIES and NFCS pain scales during the first 72 hours after surgical procedure
时间窗: Every 2-4h during the first 72 hours after surgical procedure
次要结局
- Time between surgical procedure and successful extubation(Hospital stay)
- Time between surgical procedure and achievement of 100 mL/kg of enteral feeding(hospital stay)
研究者
研究点 (1)
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