2024-512438-14-00招募中4 期
Klonidin as pain relief in eye examination of premature infants - cloROP
Region Oerebro Laen2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年7月22日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- PIPP-R scores within 30 seconds after the eye examination has been initiated, i.e. when the hooks are in place in the first eye in Uppsala or when the first eye is held open in Örebro.
研究概览
简要总结
The primary objective is to investigate whether clonidine works is a good analgesic during examination for Retinopathy of Prematurity (ROP)
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •The infant is admitted to the study clinic
- •The infants guardian/s has/have given their written consent to the child's participation in the study
- •The infant is born before gestation week 30
排除标准
- •Children who has received beta blockers, pain reliever or sedating drug within 24 hours of eye examination.
- •Previously documented kidney failure
- •Does not have a gastric tube
- •Neurologically affected
- •Known cardiac arrhythmia
- •Circulatory instability (defined as mean arterial pressure lower than the child's gestational age)
结局指标
主要结局
PIPP-R scores within 30 seconds after the eye examination has been initiated, i.e. when the hooks are in place in the first eye in Uppsala or when the first eye is held open in Örebro.
PIPP-R scores within 30 seconds after the eye examination has been initiated, i.e. when the hooks are in place in the first eye in Uppsala or when the first eye is held open in Örebro.
次要结局
- GSR: Area small peaks, area huge peaks, peaks per second och average rise time
- Number of reported AEs, SAEs and SUSARS
- A VAS scale of 0-10 cm, from very easy to examin (0) to very difficult to examin (10)
研究者
Miriam Pettersson
Scientific
Region Oerebro Laen
研究点 (2)
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