NCT02966288撤回4 期
A Randomized Controlled Trial to Assess the Pain-control Efficacy of Intra-articular Toradol Compared to Oral NSAIDs: A Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Pain Medication Usage for Breakthrough Pain
研究概览
简要总结
The study objective is to determine whether a single intra-articular dose of an anti-inflammatory (Toradol) will reduce the need for other analgesic medications and, if so, how long the benefits will last.
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
- •Patients with radiographic evidence of osteoarthritis (OA) who present to the ED with a chief complaint of knee pain that the treating provider attributes to their arthritis.
排除标准
- •Acute knee trauma
- •Intra-articular steroid injection within 6 months
- •History of gout or rheumatoid arthritis
- •X ray evidence of pathologic fracture, malignancy, or other non-OA cause of symptoms
- •Signs or symptoms or high risk of acute infection: Recent fevers and chills; Erythema, warmth, or pain out of proportion to exam; History of hemodialysis; History of IV drug use
- •Lidocaine allergy
- •Any contraindication to NSAID therapy, including: Allergy; Pregnancy; History of renal insufficiency; History of gastritis, GERD or GI bleeding; Primary care physician's restriction of its use
- •Contraindication to the procedure, including: Hemophilia; History of total knee replacement of the affected joint
- •An inability to give informed consent; Active psychosis; Diminished capacity requiring another person to provide consent for medical treatment
- •An inability to be contacted for follow-up
研究组 & 干预措施
Toradol injection
Experimental
3-ml solution that contains 2 ml of normal saline and 1 ml of Toradol, 30 mg, will be infused into the affected joint.
干预措施: Toradol (Drug)
Oral NSAID
Active Comparator
800mg Motrin will be administered. (non-steroidal anti-inflammatory drug (NSAID))
干预措施: Oral NSAID (Drug)
结局指标
主要结局
Pain Medication Usage for Breakthrough Pain
时间窗: 72 hours
Pain Level as Assessed by a Visual Analogue Scale
时间窗: 72 hours
次要结局
- Pain Medication Usage for Breakthrough Pain(4 weeks post treatment)
- Pain Level as Assessed by a Visual Analogue Scale(4 weeks post treatment)
- Number of Participants who had a second visit to a Emergency Department or Clinic(4 weeks)
研究者
Kimberly A Chambers
Clinical Assistant Professor
The University of Texas Health Science Center, Houston
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