A Randomized Study Comparing Etoricoxib and Diclofenac Sodium in Post Hallux Valgus Surgery Pain
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Patients Global Evaluation of Study Medication
研究概览
简要总结
The investigators hypothesize that cyclooxygenas-II-selective inhibitors (Coxibs) provide a better patients assessed overall satisfaction when used for pain management after elective hallux valgus surgery as compared to traditional Non-steroidal anti-inflammatory drugs (NSAIDs).
详细描述
The aim of the present study is to compare patients' satisfaction with pain medication during the first 7 first postoperative days following elective hallux valgus surgery in general anaesthesia between etoricoxib and diclofenac in a prospective randomised double-blind study design.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiology (ASA) physiological class 1-2 patients
- •aged 18-65 years
- •scheduled for elective hallux valgus surgery in general anesthesia
排除标准
- •NSAID allergy
- •liver disease
- •renal disease
- •uncontrolled cardiovascular disease
- •Lithium therapy
- •chronic pain
- •regular analgesia use
研究组 & 干预措施
etoricoxib
active study drug, coxib
干预措施: etoricoxib (Drug)
diclofenac
active traditional NSAID control
干预措施: Diclofenac (Drug)
结局指标
主要结局
Patients Global Evaluation of Study Medication
时间窗: postoperative day 1-6
Patients self-assessment of global satisfaction with pain medication
次要结局
未报告次要终点
研究者
Jan Jakobsson
Adj. Professor
Karolinska Institutet