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临床试验/NCT01006187
NCT01006187已完成3 期

Comparison of Different Analgesic Methods for Reducing Pain From Adult Intramuscular Influenza Virus Vaccine Injection

The Hospital for Sick Children1 个研究点 分布在 1 个国家目标入组 352 人开始时间: 2009年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
352
试验地点
1
主要终点
Pain from adult intramuscular influenza virus injection

研究概览

简要总结

The purpose of this study is to compare four different analgesic strategies in adults undergoing routine influenza immunization

详细描述

In this study, we will compare relative effectiveness of 4 analgesic strategies (i.e., topical local anesthetics, vapocoolant spray, tactile stimulation and distraction) in adults undergoing routine immunization in order to provide further evidence of the effectiveness of each intervention and to determine if one method is superior to another. We are not including a 'no treatment' group because we do not wish to subject participants to unnecessary pain when there are available analgesic treatments. Moreover, in the presence of a 'no treatment' group, we cannot rule out a placebo effect for all treatment groups unless we provide a matched placebo for each intervention, which is not feasible. In future studies, we plan to address the added benefit of combining analgesic interventions (i.e., evaluating the effect of a multimodal approach).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy adults aged >18 years of age undergoing voluntary immunization with influenza virus vaccine

排除标准

  • Pre-medication with any of the analgesic interventions in this study,
  • Chronic pain syndromes/conditions
  • Receiving systemic analgesics and sedatives
  • Abnormal circulation (e.g., Raynaud's phenomenon)
  • Allergy/hypersensitivity to amide local anesthetics
  • Allergy to influenza virus vaccine or constituents
  • Prior participation in the trial
  • Inability to understand the VAS
  • If suspected to be pregnant, pregnant or breastfeeding (due to possible treatment with liposomal lidocaine).

研究组 & 干预措施

Group 1

Active Comparator

1 liposomal lidocaine 4% cream .

干预措施: Liposomal lidocaine (Drug)

Group 2

Active Comparator

Vapocoolant spray

干预措施: Vapocoolant spray (Drug)

Group 3

Active Comparator

Rubbing adjacent to the injection site

干预措施: Rubbing adjacent to the injection site (Other)

Group 4

Active Comparator

Distraction by means of self-selected reading material or internet

干预措施: Distraction (Other)

结局指标

主要结局

Pain from adult intramuscular influenza virus injection

时间窗: 1 day

次要结局

  • Adverse Events(1 day)
  • Anxiety(1 hour)

研究者

申办方类型
Other

研究点 (1)

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