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临床试验/NCT05323071
NCT05323071已完成不适用

Comparison of the Effectiveness of Administering 24% Oral Sucrose Two Minutes Before Versus at the Same Time in the Performance of a Painful Procedure in the Neonate.

Oihana Lopez Alonso2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
74
试验地点
2
主要终点
Pain during a painful procedure

研究概览

简要总结

The objective of this study is to compare the use of 24% sucrose in pain control in neonates from 32 weeks of gestation onwards according to the time of administration of sucrose in venous and arterial puncture for blood collection.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
32 Weeks 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Neonates whose parents and/or guardians have signed the informed consent form.

排除标准

  • Neonates connected to invasive mechanical ventilation.
  • Neonates presenting any type of neurological alteration or showing signs of irritability prior to the puncture.
  • Neonates who have received sedation.
  • Neonates presenting withdrawal syndrome.

结局指标

主要结局

Pain during a painful procedure

时间窗: 15 seconds after extraction

The primary variable is pain, and will be measured by the Premature Infant Pain Profile-Revised (PIPP-R) scale. The score ranges from 0 (no pain or minimal pain) to 21 (maximum pain).

次要结局

未报告次要终点

研究者

发起方
Oihana Lopez Alonso
申办方类型
Network
责任方
Sponsor Investigator
主要研究者

Oihana Lopez Alonso

Neonatal unit nurse

Bioaraba Health Research Institute

研究点 (2)

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