A Multi-Center, Open-Label, Surgical Surveillance Trial To Evaluate The Safety And Efficacy Of A Shortened Infusion Time of Intravenous Ibuprofen
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 22
- 主要终点
- To Determine the Safety of a Single Dose of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.
研究概览
简要总结
The primary objective of this study is to determine the safety of a single dose of intravenous ibuprofen administered over 5-10 minutes for the preemptive treatment of postoperative pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 surgery with anticipated need for postoperative analgesia
排除标准
- •Patients with inadequate IV access
- •Patients <18 years of age
- •History or allergy or hypersensitivity to any component of intravenous ibuprofen, aspirin (or aspirin related products) or non-steroidal anti-inflammatory drug (NSAIDs)
- •Active hemorrhage or clinically significant bleeding
- •Pregnant or nursing
- •Patients in the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery
- •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
- •Refusal to provide written authorization for use and disclosure of protected health information
研究组 & 干预措施
Intravenous ibuprofen
Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.
干预措施: Intravenous ibuprofen (Drug)
结局指标
主要结局
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.
时间窗: 6 hours
The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.
时间窗: 6 hours
The incidence of treatment-emergent adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen
次要结局
- To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.(6 hours)
- To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.(6 hours)