跳至主要内容
临床试验/CTRI/2015/11/006356
CTRI/2015/11/006356进行中(未招募)2 期

Effectiveness of sucrose analgesia for procedural pain in term neonates

Kasturba Medical College1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2013年8月26日最近更新:

试验速览

阶段
2 期
状态
进行中(未招募)
入组人数
128
试验地点
1
主要终点
3-4:moderate pain

研究概览

简要总结

Neonates feel more pain than adults for the same intensity of pain stimulus.But neonatal pain is poorly understood and mostly ignored.Long term outcomes of severe neonatal pain during procedures will cause behavioural changes. Hence there is necessity to reduce pain in neonates during procedures.Sucrose is being tried as an analgesic agent for neonatal pain but in India no studies have been reported.Our hypothesis is 24% sucrose is an effective analgesic for neonatal procedural pain.

研究设计

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

入排标准

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

入选标准

  • Healthy term neonates.

排除标准

  • Neonates with severe medical illnesses.

结局指标

主要结局

3-4:moderate pain

时间窗: Day 1

more than 4:severe pain

时间窗: Day 1

SPO2

时间窗: Day 1

Heart rate

时间窗: Day 1

Mean Cry time

时间窗: Day 1

NIPS score

时间窗: Day 1

0-2:mild to no pain

时间窗: Day 1

次要结局

  • Salivary cortisol(Day 1)

研究者

申办方类型
Private medical college

研究点 (1)

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