Pain Relief of Newborn Preterm Infants During Endotracheal Suctioning: a Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- clinical pain score
研究概览
简要总结
Evaluate the effectiveness of the use of a 24% sucrose solution for pain management of preterm infants during endotracheal suctioning.
详细描述
Many infants admitted to neonatal intensive care unit (NICU) undergo repeated invasive procedures. Recent studies have shown that the oral sucrose administration to neonates is safe and effective for pain relief during heel stick and venipuncture.Most data suggest the investigation of the effect of sucrose in other painful procedures such as in ventilated newborns.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm infants
- •over 12 hours of life
- •intubated
- •clinically stable
- •without use of analgesics or sedatives
排除标准
- •preterms with congenital malformations
- •preterms with genetic syndromes
- •preterms with Apgar score at 5´<7
- •preterms with meningitis
- •preterms with diagnosed of necrotizing enterocolitis Ouvir Ler foneticamente
研究组 & 干预措施
sucrose
0,5 ml/kg of sucrose administered 2 minutes prior the procedure
干预措施: sucrose (Drug)
sterile water
0,5 ml/kg of sterile water administered 2 minutes prior the procedure
干预措施: sucrose (Drug)
结局指标
主要结局
clinical pain score
时间窗: within the first twelve hours after clinical stabilization, the PIPP will be done.
The tool that will be used is PIPP = Premature Infant Pain Profile. This avaliation begins prior to suctioning until 30 seconds after suctioning. Each infant will be avaliated 2 times (with sucrose and with placebo). The 2 avaliations in the same day.
次要结局
未报告次要终点