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临床试验/NCT01811979
NCT01811979已完成不适用

Efficacy of Oral Sucrose and Topical Anesthetics to Reduce Pain During Eye Examination

Dr. Sami Ulus Children's Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年4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
60
试验地点
1
主要终点
Premature Infant Pain Profile

研究概览

简要总结

Oral sucrose reduces pain during heel sticks and venipunctures in preterm infants. The purpose of this study was to determine the effectiveness of local anesthetic eye drops and a pacifier, plus repeated doses of 24% sucrose, to relieve pain associated with eye examinations for retinopathy of prematurity.

详细描述

Oral sucrose reduces pain during heel sticks and venipunctures in preterm infants. Administration of oral sucrose with and without non-nutritive sucking is the most frequently studied non-pharmacological intervention for procedural pain relief in neonates.The purpose of this study was to determine the effectiveness of local anesthetic eye drops and a pacifier, plus repeated doses of 24% sucrose, to relieve pain associated with eye examinations for retinopathy of prematurity.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
1 Day 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • VLBW infants <32 weeks of gestational age

排除标准

  • infants >32 weeks of gestational age
  • neuromuscular abnormality
  • major abnormality

结局指标

主要结局

Premature Infant Pain Profile

时间窗: two hours

Premature Infant Pain Profile were determined after each eye examination

次要结局

  • Crying time(two hours)

研究者

发起方
Dr. Sami Ulus Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilek Dilli

Assoc Prof

Dr. Sami Ulus Children's Hospital

研究点 (1)

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