A Multicenter, Prospective, Randomized, Double-blind Study to Determine the Efficacy of Intravenous Ibuprofen Compared to Intravenous Ketorolac for Pain Control Following Arthroscopic Knee Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Efficacy of Pain Relief (Pain Intensity at Rest)
研究概览
简要总结
The purpose of this study is to assess the efficacy of intravenous ibuprofen compared to ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for knee arthroscopy
排除标准
- •Inadequate IV access.
- •History of allergy or hypersensitivity to any component of ibuprofen, ketorolac, aspirin (or aspirin related products), non-steroidal anti-inflammatory drugs (NSAIDs), opioids or cyclooxygenase-2 (COX-2) inhibitors.
- •Less than 18 years of age.
- •Use of analgesics less than 8 hours prior to surgery.
- •Patients with active, clinically significant anemia.
- •History or evidence of asthma or heart failure.
- •Pregnant.
- •Recent history of chronic opioid use.
- •Concomitant use of probenecid.
- •Inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]), and agree to abide by the study restrictions and to return for the required assessments.
- •Refusal to provide written authorization for use and disclosure of protected health information.
研究组 & 干预措施
IV ibuprofen
800mg ibuprofen
干预措施: IV ibuprofen (Drug)
ketorolac
30mg ketorolac
干预措施: Ketorolac (Drug)
结局指标
主要结局
Efficacy of Pain Relief (Pain Intensity at Rest)
时间窗: First possible time post-surgery, an expected average of 6 hours
Pain assessed using VAS (Visual Analog Scale, VAS). The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between 0 (No Pain) and 100 (Worst Possible Pain).
Efficacy of Pain Relief (Pain Intensity With Movement)
时间窗: First possible time post-surgery, an expected average of 6 hours
Pain assessed using VAS (Visual Analog Scale, VAS). The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between 0 (No Pain) and 100 (Worst Possible Pain).
次要结局
- Rescue Medication Use in Post-operative Period(Post-operative period until discharge, an expected average of 6 hours)
- Time to First Use of Rescue Med Will be Measured(Post-operative period until discharge, an expected average of 6 hours)
- Patient Satisfaction(Post-operative period until discharge, an expected average of 6 hours)
- Incidence of Serious Adverse Events(Post-operative period until discharge, an expected average of 6 hours)