A Pilot Study Comparing the Analgesic Efficacy of IV Ibuprofen and IV Ketorolac
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The efficacy of a single dose of intravenous ibuprofen compared to a single dose of ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS).
研究概览
简要总结
The primary objective of this study is to compare the efficacy of a single dose of intravenous ibuprofen compared to a single dose of ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS).
详细描述
The primary objective of this study is to compare the efficacy of a single dose of intravenous ibuprofen compared to a single dose of ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS).
The secondary objectives of this study are:
- To compare amount of and time to rescue medication in the postoperative period between IV ibuprofen and IV ketorolac treatment groups.
- To compare time to mobility in the postoperative period between IV ibuprofen and IV ketorolac treatment groups.
- To compare time to discharge in the postoperative period between IV ibuprofen and IV ketorolac treatment groups.
- To compare the incidence of adverse events between IV ibuprofen and IV ketorolac treatment groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with a preoperative diagnosis which is inclusive of chronic pelvic pain scheduled for Laparoscopic Surgery
排除标准
- •Inadequate IV access.
- •History of allergy or hypersensitivity to any component of IVIb,ketorolac, aspirin (or aspirin related products), NSAIDs, or COX-2 inhibitors.
- •Less than 18 years of age or Greater than 65 years of age.
- •Use of analgesics, including NSAIDs, less than 12 hours prior to surgery.
- •Patients with active, clinically significant anemia.
- •History or evidence of asthma or heart failure.
- •Pregnant.
- •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.
- •Patients with a history of Chronic Pain Conditions or Syndromes excluding patients with Chronic Pelvic Pain.
- •Patients with known OSA
研究组 & 干预措施
ibuprofen versus ketoralac
IV ibuprofen (800 mg intravenous ibuprofen administered intravenously over 10 minutes) will be administered as a single dose prior to surgery at the initiation of anesthesia. A corresponding volume of NS will be administered to the group randomized to ketorolac, at the same time to maintain the study blind.
干预措施: IV Ibuprofen (Drug)
ibuprofen versus ketoralac
IV ibuprofen (800 mg intravenous ibuprofen administered intravenously over 10 minutes) will be administered as a single dose prior to surgery at the initiation of anesthesia. A corresponding volume of NS will be administered to the group randomized to ketorolac, at the same time to maintain the study blind.
干预措施: IV Ketorolac (Drug)
结局指标
主要结局
The efficacy of a single dose of intravenous ibuprofen compared to a single dose of ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS).
时间窗: One Year
次要结局
- Incidence of adverse events between IV ibuprofen and IV ketorolac treatment groups(One Year)
- Amount of and time to rescue medication in the postoperative period between IV ibuprofen and IV ketorolac treatment groups(1 Year)
- Time to mobility in the postoperative period between IV ibuprofen and IV ketorolac treatment groups(One Year)
- Time to discharge in the postoperative period between IV ibuprofen and IV ketorolac treatment groups(One Year)
研究者
Khalid Athar M.D.
Medical Director
Culpeper Surgery Center