NCT00225732已完成3 期
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of Ibuprofen Injection (IVIb) for Treatment of Pain in the Post-Operative Adult Patients
Cumberland Pharmaceuticals13 个研究点 分布在 2 个国家目标入组 319 人开始时间: 2005年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 319
- 试验地点
- 13
- 主要终点
- Change in the Patient Demand for the Narcotic Analgesic, Morphine, Post Surgery
研究概览
简要总结
The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative hospitalized adult patients every 6 hours for 48 hours is to determine the efficacy of Caldolor compared to placebo for the treatment of post-operative pain as measured by reduction in the requirement for the narcotic analgesic, morphine, post 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Scheduled for elective abdominal hysterectomy surgery with anticipated need for post-operative I.V. morphine analgesia with anticipated use of ≥ 24 hours.
- •Adequate IV access
- •Anticipated hospital stay ≥ 24 hours
排除标准
- •Be unable to make a reliable self-report of pain intensity to pain relief
- •Less than 18 years of age
- •Greater than 70 years of age
- •Use of NSAIDs within 12 hours prior to dosing
- •Use of analgesics, muscle relaxants and sedatives less than 24 hours prior to CTM administration with the following exceptions: paracetamol (acetaminophen) can be administered until 6 hours prior to surgery; tramadol can be administered until midnight the evening prior to surgery; muscle relaxants working at the neuromuscular junction used for intubation and/or anesthesia administration for the surgical procedure prior to CTM administration; and sedatives (i.e., midazolam) used as a co-induction agent for the surgical procedure prior to CTM administration
- •Patients taking warfarin, lithium, combination of ACE-inhibitors and furosemide
- •Patients with anemia (active clinically significant) and/or a history or evidence of asthma or heart failure
- •History of allergy or hypersensitivity to any component of Caldolor, aspirin (or aspirin related products), NSAIDs, or COX-2 inhibitors
- •Pregnant or nursing
- •History of severe head trauma that required current hospitalization, intracranial surgery or stroke within the previous 30 days, or any history of intracerebral arteriovenous malformation, cerebral aneurysm or CNS mass lesion
- •Weigh less than 30kg
- •Have a history of congenital bleeding diathesis (eg hemophilia) or any active clinically significant bleeding, or have underlying platelet dysfunction including (but not limited to) idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, or congenital platelet dysfunction
- •Have GI bleeding that required medical intervention within the previous 6 weeks (unless definitive surgery has been performed)
- •Have a platelet count less than 30,000mm3 determined within the 28 days prior to surgery
- •Pre-existing dependence on narcotics or known tolerance to opioids
- •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
- •Be on dialysis, have oliguria or calculated creatinine clearance of less than 60 mL/min (calculated using the Cockcroft and Gault formula) determined within the 28 days prior to surgery
- •Inability to achieve hemostasis or inability to close surgical incision, prior to Operating Room discharge
- •Operative procedure includes organ transplant
- •Pre or intra-operative procedure utilized for the prevention of pre- or post-operative pain (i.e. epidural or nerve blocks)
- •Be receiving full dose anticoagulation therapy or Activated Protein C within 6 hours before dosing (Prophylaxis with subcutaneous heparin is acceptable)
- •Have received another investigational drug within the past 30 days
- •Be otherwise unsuitable for the study in the opinion of the investigator
研究组 & 干预措施
intravenous ibuprofen
Active Comparator
干预措施: Intravenous ibuprofen (Drug)
normal saline
Placebo Comparator
干预措施: Normal saline as placebo comparator (Other)
结局指标
主要结局
Change in the Patient Demand for the Narcotic Analgesic, Morphine, Post Surgery
时间窗: 24 Hours
Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post-surgery
次要结局
未报告次要终点
研究者
研究点 (13)
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