Registration and Treatment of Pain During Eye Examination of Prematurity
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- pain
研究概览
简要总结
The aim of this study is to see if paracetamol has a pain-relieving effect during eye examination in premature infants.
详细描述
Retinopathy of prematurity (ROP) is a feared complication of premature birth. If discovered in time, the disease can be treated, and impaired vision or blindness can be reduced. Premature infants are therefore examined regularly after birth. However, the examination is painful and stressful for the infant. Painful experiences might lead to a pathological stress response later in life and should therefore be prevented.
This is a double blinded, controlled and randomized study where the infants are examined and assessed either with or without the use of paracetamol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 31 Weeks 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants < 32 weeks of gestational age (< 31+6 weeks)
排除标准
- •Infants with ongoing analgesic treatment
研究组 & 干预措施
paracetamol
Paracetamol mixture 20 mg/kg + pacifier and sucrose
干预措施: paracetamol (Drug)
placebo
pacifier and sucrose only
干预措施: sucrose (Drug)
结局指标
主要结局
pain
时间窗: 5 minutes
Premature Infant Pain Profile (PIPP): score range 0-21. Used independently by 2 experienced observers
次要结局
未报告次要终点