Efficacy of PENNSAID® for Pain Management in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in pain score
研究概览
简要总结
The primary objective of this study is to compare the pain relieving effect and speed of onset of PENNSAID to that of standard oral diclofenac under double blind conditions using a growth curve approach to pain measurement. The investigators will test the hypothesis that PENNSAID will provide more rapid pain relief than oral diclofenac during the ED visit. The secondary goal of the proposed work is to discover and model the onset and course of pain relief during the emergency department (ED) visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Pennsaid
Active Pennsaid and oral placebo
干预措施: PENNSAID (Drug)
Oral Diclofenac
Oral diclofenac and placebo lotion (2.3% DMSO solution)
干预措施: Diclofenac hydroxyethylpyrrolidine (Drug)
结局指标
主要结局
Change in pain score
时间窗: Measure at 5 minute intervals for the duration of the ER visit
Compare the pain relieving effect and speed of onset of PENNSAID to that of standard oral diclofenac.
次要结局
- pain trajectory model(nine months)