A Pilot Study to Determine the Efficacy of Intravenous Ibuprofen 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
- 51
- 试验地点
- 1
- 主要终点
- Efficacy of IV Ibuprofen for Post-op Pain.
研究概览
简要总结
The intent of this study is to assess the analgesic efficacy of IV ibuprofen when administered at induction of anesthesia. Results from this pilot study will be used to design and determine the appropriate statistical power for a larger, multi-center randomized study.
详细描述
Non-steroidal anti-inflammatory drugs(NSAIDs) are an effective adjunct to opioid analgesia for moderate-severe pain, with improvement in the quality of pain relief and consistent evidence of opioid dose sparing. NSAIDs alone could provide effective analgesia post-surgery when mild-moderate pain is expected. There is also evidence that the use of NSAIDs, by avoiding or decreasing the need for opioids, can lead to a reduction in the incidence of adverse events which are commonly attributed to, or exacerbated by, opioids.
The intent of this study is to assess the analgesic efficacy of IV ibuprofen when administered at induction of anesthesia. Results from this pilot study will be used to design and determine the appropriate statistical power for a larger, multi-center randomized study.
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 intravenous (IV) access.
- •History of allergy or hypersensitivity to any component of ibuprofen or other NSAIDs, aspirin (or aspirin related products), 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 non-steroidal anti-inflammatory drug (NSAID) or opioid use.
- •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
Intravenous ibuprofen (800 mg) administered intravenously over 10 minutes at study hour 0 and again at study hour 4 (Ibuprofen arm) and a corresponding volume of normal saline (ketorolac arm) will be administered intravenously over no less than 15 seconds at the end of the arthroscopic procedure
干预措施: IV ibuprofen (Drug)
IV ketorolac
A corresponding volume of normal saline (Ibuprofen arm) administered intravenously over 10 minutes at study hour 0 and again at study hour 4 and 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) (ketorolac arm) will be administered intravenously over no less than 15 seconds at the end of the arthroscopic procedure
干预措施: IV ketorolac (Drug)
结局指标
主要结局
Efficacy of IV Ibuprofen for Post-op Pain.
时间窗: first possible assessment following surgery
Measurement of the efficacy of IV ibuprofen for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS) upon first possible assessment following surgery. 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 o and 100.
次要结局
- Time to Discharge.(24 hours)
- Incidence of Serious Adverse Events (SAEs).(24 hours)
- Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Amount of Time to Rescue Medication in the Postoperative Period Through Discharge(24 hours)
- Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Pain Intensity as Assess by Patient Pain Intensity (VAS) in the Post-surgical Period, Through 24 Hours(24 Hours)
- Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Amount of Rescue Medication in the Postoperative Period Through Discharge(24 hours)
- Patient Satisfaction.(24 hours)