Effect of Toradol on Post-operative Foot and Ankle Healing
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 128
- 主要终点
- Visual analog score for pain
研究概览
简要总结
The use of Toradol for pain control in surgical orthopedic cases is currently a topic of interest within the field. The proposed study is a prospective randomized study evaluating postoperative pain, opioid requirement, complication/reoperation rates and nonunion rates in patients undergoing surgical treatment for isolated lateral malleolar fibula fractures. Patients will be randomized to either the Treatment Group (Toradol) or the Control Group (Non-Toradol). Both Toradol and non-Toradol drug regimens are currently prescribed by the Foot and Ankle Team at the Rothman Institute and this study will serve as a valuable comparison.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients over age of 18 undergoing outpatient open reduction and internal fixation (ORIF) by a fellowship-trained foot and ankle orthopaedic surgeon for isolated lateral malleolar, bimalleolar, or trimalleolar ankle fractures.
排除标准
- •open fracture
- •allergies to one or more of the study medications
- •existing use of narcotics
- •renal insufficiency as defined by history and preoperative creatinine level
- •pregnancy
- •hospital admittance
研究组 & 干预措施
Control
To the control group post ankle fracture surgery, per subject 30 tablets of 5/325 oxycodone-acetaminophen with instructions to take 1 or 2 tabs every 4 to 6 hours as needed for pain
干预措施: No ketorolac (Other)
Intervention
To the treatment group post ankle fracture surgery, per subject 30mg of IV ketorolac intraoperatively; 20 tablets of 10mg ketorolac with instructions to take every 6 hours, and 30 tablets of 5/325 oxycodone-acetaminophen with instructions to take 1 or 2 tabs every 4 to 6 hours as needed for pain
干预措施: Ketorolac (Drug)
结局指标
主要结局
Visual analog score for pain
时间窗: Days 1-7 post-op
To evaluate the pain VAS scores of all patients
次要结局
- Opioid pill intake(Days 1-7 post-op)
- Radiographic healing(12-33 weeks)
研究者
Tiffany Morrison, MS
Director of Clinical Trials
Rothman Institute Orthopaedics