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临床试验/CTRI/2025/02/081266
CTRI/2025/02/081266尚未招募不适用

Comparative assessment of pain reduction with topical EMLA and physical pain blocker in primary whole cell DPT vaccination using neonatal infant pain scale -an open labelled randomized control trial

vinayaka missions research foundation deemed university1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年3月8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
80
试验地点
1
主要终点
pain reduction comparison between emla cream and physical pain blocker.

研究概览

简要总结

immunization is an important cost effective public health intervention to control vaccine preventable infectious diseases among children. Though pharmacological interventions are available to reduce pain of vaccine pricks , they are not widely practiced in India due to high burden on health care infrastructure and manpower.in this setting nonpharmacological methods which are safe, easily available, more accessible and acceptable may prove useful if their physiological actions are understood and efficacy proven by trials.

In this regard, this study intends to compare pain reduction efficacy of physical method of using pain blocker with standard topical EMLA (eutectic mixture of local anesthetics) cream application for vaccination pain associated with whole cell Diphtheria Pertussis Tetanus containing pentavalent vaccine for the three primary doses. The pain would be measured with standard NIPS (NEONATAL INFANT PAIN SCALE).

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
1.50 Month(s) 至 3.50 Month(s)(—)
性别
All

入选标准

  • healthy infants of 6,10- and 14-weeks gestation.

排除标准

  • infants who are nicu graduates 2)infants with congenital anomalies, dysmorphism, hearing or vision abnormalities identified at birth 3)infants who suffer from illness which are acute or may extend long term.
  • infants on medications other than vitamin supplements.

结局指标

主要结局

pain reduction comparison between emla cream and physical pain blocker.

时间窗: assessed at the time of vaccination administered at 6weeks,10 weeks and 14 weeks

次要结局

  • comparison of pain at 6th,10th & 14th week of life(assessed at the time of vaccination administered at 6weeks 10 weeks & 14 weeks)

研究者

发起方
vinayaka missions research foundation deemed university
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Amrin Taaj I

vinayaka missions medical college and hospital,karaikal

研究点 (1)

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