NCT01872871Unknown不适用
The Efficacy of Paracetamol in Reducing Pain During Ophthalmological Examination for Retinopathy of Prematurity: a Prospective Randomised Trial
Dr. Sami Ulus Children's Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Reducing pain assessment score
研究概览
简要总结
Retinopathy of prematurity (ROP) is one of the major morbidity among preterm infants. Although, local anesthetics reduce pain to some extent, eye examination still remains as a painful procedure. The investigators aimed to evaluate the effect of oral paracetamol combined with local anesthetics for pain relief during ophthalmological examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gestational age below 32 weeks or birth weight below 1500 grams
排除标准
- •congenital anomalies, necrotising enterocolitis, surgical problems
研究组 & 干预措施
local anasthetic drops
Placebo Comparator
topical anaesthetic drop with placebo
干预措施: Topical anaesthetic drop with placebo (Drug)
Paracetamol
Active Comparator
Topical anaesthetic drop with Paracetamol
干预措施: Paracetamol (Drug)
结局指标
主要结局
Reducing pain assessment score
时间窗: 2 weeks
次要结局
未报告次要终点
研究者
Serdar Beken
M.D.
Dr. Sami Ulus Children's Hospital
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Pain Management During Screening for Retinopathy of PrematurityPain ManagementRetinopathy of PrematurityNCT04767178Istanbul Medeniyet University44
进行中（未招募）
1 期
The Preterm infants’ Paracetamol Study -- PreParaSpremature infantMedDRA version: 16.0 Level: LLT Classification code 10036615 Term: Prematurity System Organ Class: 100000004868EUCTR2013-001842-33-FIOYS240
已完成
1 期
Extremely Low Gestatonal Age Infants' Paracetamol StudyLow Birthweight, Extremely (999 Grams or Less)Extreme PrematurityNCT03641209Outi Aikio40
招募中
4 期
Clonidine as Pain Relief During ROP Eye ExaminationsPain, ProceduralPremature Infant DiseaseRetinopathy of PrematurityNCT04902859Region Örebro County50
招募中
2 期
Oral Propranolol for Prevention of Threshold Retinopathy of PrematurityRetinopathy of PrematurityNCT03083431University of Zurich276