Comparison of Different Analgesic Methods for Reducing Pain From Adult Intramuscular Influenza Virus Vaccine Injection
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
- 是
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
1 liposomal lidocaine 4% cream .
干预措施: Liposomal lidocaine (Drug)
Group 2
Vapocoolant spray
干预措施: Vapocoolant spray (Drug)
Group 3
Rubbing adjacent to the injection site
干预措施: Rubbing adjacent to the injection site (Other)
Group 4
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)
