NCT01235637已完成3 期
Efficacy of Alfentanyl Versus Sufentanyl in Children for Pain During Treatment by Tracheal Suction in an Intensive Care Unit.
University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年6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
- 40
- 试验地点
- 1
- 主要终点
- COMFORT score
研究概览
简要总结
The main objective is to assess the efficacy of Alfentanil for pain in children treated by tracheal suction in pediatric intensive care units in France, compared to Sufentanyl, the current standard treatment.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Month 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •child between 1 month and 15 years of age
- •affiliation to the French social security system or equivalent
- •child receiving mechanical ventilation for at least 4 hours and less than 48 hours
- •ventilation to be provided for at least 8 hours
- •less than 30 days in pediatric intensive care
- •child under intravenous sedation
- •consent of both parents
- •consent of child when possible
排除标准
- •curarized child
- •ketamine treatment
- •children suffering from facial and/or severe brain traumatism
- •known hypersensitivity reaction to morphine or intolerance insufficiency to sufentanyl
- •respiratory
- •chronic obstructive pulmonary disease
- •myasthenia
- •treatment with morphine agonists-antagonists, or combination with MAOIs
- •renal or liver disorders
- •preterm birth of more than one month of life (but not at full term by corrected age)
- •associated treatment or pathology contra-indicating administration of Sufentanyl epidural
研究组 & 干预措施
Alfentanil
Active Comparator
干预措施: Alfentanil (Drug)
Sufentanil
Sham Comparator
干预措施: Sufentanil (Drug)
结局指标
主要结局
COMFORT score
时间窗: 8 hours
pain score recommended in pediatric intensive care units in France
次要结局
- Hemodynamic criteria(8 hours)
- Bispectral Index score(8 hours)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Pediatric Pain Optimization After TonsillectomyObstructive Sleep ApneaPain, ProceduralTonsillitisNCT05244226Duke University66
已完成
不适用
The Effects of Remifentanil and Remifentanil-Alfentanil Administration in ChildrenAdverse Effect of Other General AnestheticsNCT02486926Hallym University Medical Center102
终止
3 期
Intranasal Fentanyl Versus Oral Morphine Sulfate in the Treatment of Pain in Pediatric TraumaPain, AcuteNCT03063359University Hospital, Montpellier22
已完成
不适用
Intranasal Fentanyl for Pain Control During First-Trimester Uterine AspirationPain UterusNCT03057041University of Hawaii107
已完成
不适用
Effect of a Bolus of 10 µg/kg of Alfentanil on the Pupillary Pain IndexPainAnesthesiaNCT02646592Pr Isabelle CONSTANT14