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临床试验/CTRI/2012/07/002780
CTRI/2012/07/002780已完成不适用

“Vaccination related pain: randomized controlled trial, comparison of pain of two injection techniquesâ€

JSS Medical college1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2008年2月12日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
The primary outcome measured was immediate infant pain response assessed using the Modified Behavior Pain Score which was scored from the videotape analysis.

研究概览

简要总结

Methodology: In this Randomised Controlled Trial, source of data were 200 healthy infants of age group 6 weeks to one and half years, receiving routine intramuscular vaccination. They were divided randomly using computer generated random numbers into Standard group receiving immunisation using standard slow technique with aspiration and Pragmatic group receiving immunisation using “pragmatic†technique without aspiration. The entire vaccination procedure was videotaped. Videos were scored for pain using Modified Behavior Pain Score by 2 clinical psychologists and the mean score was considered for analysis. Pain was scored within 15 s of the immunization were measured and described the child’s maximal pain response to the injection. Cry time was measured from the start of cry till it ends by a different person. Entire data was entered in a preformed proforma. The Z test for two sample population means was used for statistical analysis.

Results: Standard technique required a longer duration (5-10 sec) when compared to pragmatic technique (1-2 sec). Mean Post vaccination MBPS in standard Group was 8.4 and in Pragmatic Group was 7.8 which was statistically significant. Crying duration in pragmatic group was less (32.1 sec) than standard group (37.37sec).

Conclusion: The “standard†slow technique was significantly more painful and took longer to administer than the “pragmatic†rapid technique.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
42.00 Day(s) 至 18.00 Month(s)(—)
性别
All

入选标准

  • All healthy infants of age group 6 weeks to one and half years receiving routine intramuscular DTwP vaccination.

排除标准

  • Any criteria which precludes immunization.

结局指标

主要结局

The primary outcome measured was immediate infant pain response assessed using the Modified Behavior Pain Score which was scored from the videotape analysis.

时间窗: post immunization pain score within 15 sec of the immunization

次要结局

  • The secondary outcome measures included infant crying time assessed from videotapes.(start of cry to till it ends)

研究者

申办方类型
Private medical college

研究点 (1)

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