跳至主要内容
临床试验/CTRI/2019/12/022572
CTRI/2019/12/022572尚未招募不适用

Randomized control trial to compare effect of time after sucrose administration on preterm neonatal pain control during heel prick

Pramukhswami Medical College1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
1
主要终点
PIPP Score at the end of procedure

研究概览

简要总结

International Association for the Study of Pain defines pain as an unpleasant sensory and emotional experience associated with actual or potential tissue damage [1]. Repeated painful exposures can have deleterious consequences. These consequences include altered pain sensitivity (which may last into adolescence) and permanent neuroanatomic and behavioral abnormalities, as found in animal studies.

Neonates admitted to NICU receive multiple painful procedures as a part of their medical management and care. They are frequently exposed to repeated procedural pain and experience significant stress during critical period of physiological vulnerability and rapid neurological development.

Neonates and more predominantly preterm neonates have the nociceptive circuitry but this system is functionally immature [2,3]. Cutaneous nociceptors fields are large in the neonates, and peripheral sensory fibers are extremely sensitive to tissue injury and have reduced peak firing frequencies.[2-5] They also have low discriminatory ability to discriminate between noxious and non-noxious stimuli.[6,7] Subpalate Neurons which are a important of Thalamic efferent circuitry connecting thalamus to cerebral cortex and Preoligiodendrocytes which are precursors to myelin producing oligodendrocytes are particularly vulnerable to pain, and may undergo apoptosis following exictotoxic free radical or inflammatory damage.[8,9] Multiple studies have shown the benefits of sucrose on neonatal pain reduction.[10-12] However, ideal sucrose administration time before the pain stimuli has not been studied adequately.

As per previous study in our instutite pain was reduce if sucrose given before 30 seconds,hence we belived that even sucrose given before 15 second of heel prick it would reduce pain so we  want to know  that sucrose <15 second before the procedure reduces  the neonatal pain by randomized control trial to compare effect of time after sucrose administration on preterm neonatal pain control during heel prick.

研究设计

研究类型
Interventional
分配方式
Stratified block randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
0.00 Day(s) 至 90.00 Day(s)(—)
性别
All

入选标准

  • All neonates with gestation from 28 weeks to 36 weeks.

排除标准

  • Neonates on invasive ventilator (non cpap) Clinically evident abnormal neurological signs have received analgesic or sedative in last 24 hours.

结局指标

主要结局

PIPP Score at the end of procedure

时间窗: PIPP Score at the end of procedure

次要结局

未报告次要终点

研究者

申办方类型
Private medical college

研究点 (1)

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