Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic ACL Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Postoperative Visual Analogue Scale Scores
研究概览
简要总结
- The investigators aim to examine the use of IV and oral ketorolac as an adjunctive agent to the standard of care pain protocol for postoperative pain control following ACL reconstruction surgery.
- The investigators hypothesize that the use of IV and oral ketorolac in addition to the standard of care pain protocol will reduce postoperative opioid consumption following ACL reconstruction surgery.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients between 18 and 89 years old
- •Patients undergoing primary anterior cruciate ligament (ACL) reconstruction surgery
排除标准
- •Patients below age 18 or above age 89
- •Illiterate or non-English speaking individuals
- •Patients with contraindications to Ketorolac
- •History of chronic alcohol or drug abuse
- •Chronic use of psychotropic or analgesic drugs
- •Known peptic ulcer disease or bleeding diasthesis
- •Renal dysfunction (estimated glomerular filtration rate < 50 mL/min/1.73m2)
- •Breastfeeding women
- •Pregnant women
研究组 & 干预措施
Control
Patients receive oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for pain following ACL reconstruction surgery
干预措施: Oxycodone-Acetaminophen (Drug)
Ketorolac
Patients receive IV ketorolac followed by ketorolac 10 mg every 6 hours for 3 days following ACL reconstruction surgery. Patients are additionally discharged with oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for additional pain control
干预措施: Ketorolac (Drug)
结局指标
主要结局
Postoperative Visual Analogue Scale Scores
时间窗: Up to 8 weeks postoperative
Patients will record their pain on a visual analogue scale with a minimum score of 0 and a maximum score of 100 where lower values indicate a lower pain level, and higher values indicate a higher pain level.
次要结局
- Narcotic Medication(5 days)
研究者
Michael Karns, MD.
Principal Investigator
University Hospitals Cleveland Medical Center