跳至主要内容
临床试验/CTRI/2020/07/026860
CTRI/2020/07/026860尚未招募不适用

The effectiveness of the combination of sucrose and other non pharmacological methods over other non pharmacological methods alone in procedural pain management in neonates

Pragna hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年8月13日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
PIPP (Premature infant pain profile)

研究概览

简要总结

Infants hospitalized in NICU undergo frequent painful tissue-breaking procedures for diagnostic and therapeutic purposes .There are some studies established the use of sucrose 24% and other non pharmacological methods in pain management in NICU. My study is done to know whether there is significance difference between the combination of sucrose, non nutritive sucking and facilitative tucking over sterile water , non nutritive sucking and facilitative tucking in reducing heel prick pain in newborns. In this study neonates who will undergo heel prick are randomized into two groups. One group receives 24% sucrose solution, non nutritive sucking , facilitated tucking and other group receives sterile water (placebo) , non nutritive tucking , facilitated tucking. Pain score PIPP ( Premature infant pain profile ) will be assessed at 30 seconds and 2 minutes following heel prick . Duration of cry and adverse events will also be assessed following heel prick.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
1.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • Neonates who require heel prick for blood glucose measurement, preterm neonates > 32 weeks and term neonates.

排除标准

  • Infants older than 28 days, neonates with congenital anomalies,APGAR score < 7 at 5 minutes, sedated neonates, neonates who had undergone surgery and in post op period, Neonates at high risk for Necrotizing enterocolitis.
  • asphyxiated neonates and neonates with feeding intolerance.

结局指标

主要结局

PIPP (Premature infant pain profile)

时间窗: 30 seconds | 2 minutes

次要结局

  • Duration of cry and(immediate adverse events)

研究者

发起方
Pragna hospital
申办方类型
Private hospital/clinic

研究点 (1)

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