The Effect of Sucrose on Pain Relief During Venous Blood Sampling in Preterm Infants: a Comparison of Two Different Doses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- pain
研究概览
简要总结
Despite the fact that oral sucrose is the most frequently studied non-pharmacological intervention for procedural pain relief in infants, there is a paucity of data on the minimal effective dose. The aim of this study is to find the minimal effective dose of sucrose to reduce pain during a single venous blood sampling procedure.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •born preterm
- •more than 1000 gram
排除标准
- •severe intraventricular hemorrhage
- •cerebral malformations
- •other malformations requiring surgery
- •medication that may impair pain expression (opioids, paracetamol, sedatives)
研究组 & 干预措施
0.2 ml sucrose
on 2 occasions within 1 week 0.2 ml sucrose 25% or 0.5 ml sucrose 25% will be given in randomized order to the same infant during blood sampling
干预措施: 0.2 ml sucrose 25% (Other)
0.2 ml sucrose
on 2 occasions within 1 week 0.2 ml sucrose 25% or 0.5 ml sucrose 25% will be given in randomized order to the same infant during blood sampling
干预措施: 0.5 ml sucrose 25% (Other)
0.5 ml sucrose
on 2 occasions within 1 week 0.2 ml sucrose 25% or 0.5 ml sucrose 25% will be given in randomized order to the same infant during blood sampling
干预措施: 0.2 ml sucrose 25% (Other)
0.5 ml sucrose
on 2 occasions within 1 week 0.2 ml sucrose 25% or 0.5 ml sucrose 25% will be given in randomized order to the same infant during blood sampling
干预措施: 0.5 ml sucrose 25% (Other)
结局指标
主要结局
pain
时间窗: 1 week
assessed by Premature Infant Pain Profile-Revised (PIPP-R). Pain score related to the blood sampling will be performed two times: at skin puncture and immediately after the needle has been removed
次要结局
未报告次要终点