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临床试验/NCT01721083
NCT01721083已完成4 期

Comparison of Two Methods of Immunization for Intramuscular Injections

Christiana Care Health Services1 个研究点 分布在 1 个国家目标入组 511 人开始时间: 2012年10月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
511
试验地点
1
主要终点
Perceived pain

研究概览

简要总结

This study is designed to compare two different styles of intramuscular injection (Bunch versus Z-Track)during flu vaccination with the following outcome measures as basis for comparison: perceive pain, redness, medication leakage, other complications within 72 hours in healthy adult volunteer subjects.

详细描述

This study is designed to compare two different styles of intramuscular injection (Bunch versus Z-Track)during flu vaccination with the following outcome measures as basis for comparison: perceive pain, redness, medication leakage, other complications within 72 hours in healthy adult volunteer subjects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •healthy adults without latex allergy over 18 years of age

排除标准

  • •latex allergy
  • •18 years or less

研究组 & 干预措施

Z-Track immunization

Experimental

Subject receives Intramuscular injection by z-track method during flu vaccination given by employee health Registered Nurse into deltoid muscle.

干预措施: Procedure: Z-track (Procedure)

Bunch immunization

Active Comparator

Subject receives Intramuscular injection by bunch method during flu vaccination given by employee health Registered Nurse into deltoid muscle.

干预措施: Procedure: Bunch (Procedure)

结局指标

主要结局

Perceived pain

时间窗: 72 hours

Subjects will be asked to rate perceived pain on scale of 0-10

次要结局

  • Medication leakage(72 hours)
  • Redness at injection site(72 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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