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临床试验/CTRI/2011/06/001783
CTRI/2011/06/001783已完成4 期

Comparision of the antinociceptive effect of topical EMLA cream with breast feeding, topical EMLA cream with distilled water & topical placebo cream with distilled water, during first DPT vaccination in healthy term infants

LLRM Medical College1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2009年1月10日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Duration of first cry in infants observed for 3 minutes

研究概览

简要总结

Abstractxml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

Objective: To compare efficacy in pain reduction due to wDPT using  (a) EMLA cream along with breast feeding (EB group) and (b) EMLA cream with oral distilled water (EW group) as compared to placebo cream with oral distilled water (PCW group). Methods: Design: A Randomized, double blind, placebo controlled trial. Setting: The immunization clinic of Department of Pediatrics, xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /LLRM Medical College, Meerut. Participants: Infants less than 3months of age who visited immunization clinic for their 1st DPT vaccination, they were randomized in three groups of 30 each. Outcome measure: The primary outcome variable was the duration of cry after vaccination. Secondary outcome variables were latency of onset of cry and Modified Facial Coding Score.

Results: 30 babies were enrolled in each of 3 groups. Median (IQR) of duration of cry was least 34.6 (24.1-72.2) seconds in EB group, followed by 94.2 (46.1-180) seconds in EW group as compared to 180.0 (180-180) seconds in PCW group (P<0.05).  Mean (95%CI) of latency of cry was significantly more in EB group 2.4 (1.9-2.8) seconds) and EW group 1.9(1.7-2.1) seconds) as compared to babies in PCW 1.5 (1.3-1.6) seconds) (P<0.05) but the difference between EB and EW group was not significant. Modified Facial Coding Score at 1min and 3min was significantly lower in EB group as compared to EW and PCW group(P<0.05).

Conclusions: Topical EMLA application is effective in reducing pain due to DPT vaccination in young infants up to 3 months of age. It has synergistic effect in analgesia when combined with breast feeding during vaccination.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
1.50 Month(s) 至 3.00 Month(s)(—)
性别
All

入选标准

  • Full term healthy infant, less than three months of postnatal age, either exclusive or partially breast fed, who will attend the immunization clinic for first DPTvaccine according to universal immunization program.

排除标准

  • 1.All infants who have required hospital admission more than 48 hrs.2.Preinatal asphyxia (5 min Apgar Score <5) or delayed cry if born at home.3.Intrauterine growth retardation (IUGR) i.e wt <10th centile for gestational age4.Preterm deliveries (<37 week of gestation )5.Previous surgery.

结局指标

主要结局

Duration of first cry in infants observed for 3 minutes

时间窗: Just after the DPT vaccination

次要结局

  • Latency of onset of cry(Modified neonatal Facial Coding Score)

研究者

发起方
LLRM Medical College
申办方类型
Government medical college

研究点 (1)

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