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临床试验/NCT02344368
NCT02344368已完成不适用

The Effect of Sucrose on Pain Relief During Venous Blood Sampling in Preterm Infants: a Comparison of Two Different Doses

Norwegian University of Science and Technology2 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2015年1月最近更新:
适应症

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

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)

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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