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临床试验/NCT00847028
NCT00847028Unknown不适用

Oral Glucose Solution as Pain Relief in Newborns: Results of a Clinical Trial

Universiteit Antwerpen2 个研究点 分布在 1 个国家目标入组 304 人开始时间: 2007年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
304
试验地点
2
主要终点
Pain after venipuncture measured by the Leuven pain scale for newborns

研究概览

简要总结

This study investigates which concentration of glucose is most effective in reducing pain for venipuncture in the newborn.

详细描述

This double-blind clinical trial is conducted on a maternity and newborn (N*) ward. Each time, during at least one month, one of the four selected solutions (glucose 10%, 20%, 30% and placebo) will be administered orally, 2 minutes prior to the venipuncture. The pain from the skin puncture will be scored using a validated pain scale (the "Leuven" pain scale).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Pain after venipuncture measured by the Leuven pain scale for newborns

时间窗: solution administration- waiting for 2 minutes-then venipuncture and immediate pain scoring

次要结局

  • difference in heart rhythm(heart rhythm measured before painful procedure - heart rythm after venipuncture compared to baseline measurement)

研究者

申办方类型
Other

研究点 (2)

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