Are NSAIDs Effective Enough for Postoperative Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
研究概览
简要总结
The purpose of this study is to compare the level of pain control in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs) to those receiving opioids in the postoperative period after endoscopic sinus surgery (ESS) and/or septoplasty.
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
- None
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
- •english speaking
- •candidates for endoscopic sinus surgery as determined by medical necessity by the treating rhinologist
- •scheduled for surgery at Texas Sinus Institute
排除标准
- •allergy to either NSAIDs or opioids
- •contraindication to NSAIDs (ex. gastritis, chronic kidney disease)
- •surgical plan exceeding basic endoscopic sinus surgery
- •use of anticoagulation
- •the presence of any pain disorder
- •the current usage of any analgesic medication
- •history of opioid addiction
- •pregnancy
- •history of chronic pain or fibromyalgia
- •current daily use of NSAIDs, acetaminophen, opioids or other analgesics (pregabalin, tramadol, etc)
研究组 & 干预措施
NSAID
The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.
干预措施: diclofenac (Drug)
opioid
The Opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).
干预措施: Norco (Drug)
结局指标
主要结局
Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
时间窗: 24 hours (day 1 after operation)
The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.
次要结局
- Number of Participants With Constipation(5 days after operation)
- Number of Participants With Nausea or Vomiting(5 days after operation)
- Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)(120 hours (day 5 after operation))
- Number of Participants With Bleeding Complications(5 days after operation)
研究者
Martin J Citardi, MD
Professor and Chairman, Department of Otorhinolaryngology - Head and Neck Surgery
The University of Texas Health Science Center, Houston