NCT00606489已完成3 期
A Multicenter, Randomized, Double-blind, Placebo-Controlled Trial of Ibuprofen Injection (IVIb) for Treatment of Fever and Pain in Burn Patients
Cumberland Pharmaceuticals5 个研究点 分布在 2 个国家目标入组 61 人开始时间: 2007年11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
- 61
- 试验地点
- 5
- 主要终点
- Temperature
研究概览
简要总结
The primary objective of this study of Caldolor administered to hospitalized adult and pediatric burn patients is to determine the efficacy of Caldolor on reducing fever when compared to placebo when administered every 6 hours for at least 24 hours.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with second and/or third degree thermal burns covering more than 10 percent total body surface area (including face) with anticipated hospital stay greater than 72 hours.
- •Adequate intravenous access
- •Have fever, documented by temperature greater than or equal to 38.0 degree celsius (100.4 degree fahrenheit)
排除标准
- •Patients with electric burns
- •Use of acetaminophen, non-steriodal anti-inflammatory agents (NSAIDs) or other fever reducing medications within 4 hours prior to dosing
- •Patients taking warfarin or lithium
- •Active, clinically significant asthma
- •History of allergy or hypersensitivity to any component of intravenous ibuprofen, NSAIDs, aspirin (or related products), 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 aneurism or central nervous system mass lesion
- •Have a history of congenital bleeding diathesis (e.g. 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 gastrointestional bleeding that required medical intervention within the previous 6 weeks (unless definitive surgery has been performed)
- •Have a platelet count less than 20,000 mm^3
- •Be on dialysis
- •Be receiving full dose anticoagulation therapy or Activated Protein C within 6 hours before dosing (clopidogrel, prophylaxis with enoxaparin or subcutaneous heparin is acceptable)
- •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 (If the patient is incapacitated, informed consent will be sought from a legally acceptable representative.)
- •Refusal to provide written authorization for use and disclosure of protected health information (If the patient is incapacitated, informed consent will be sought from a legally acceptable representative.)
- •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
1
Placebo Comparator
干预措施: Placebo (Drug)
2
Experimental
干预措施: Caldolor (Drug)
结局指标
主要结局
Temperature
时间窗: 0 to 24 hours
Area under the curve temperature from baseline to hour 24 following initiation of treatment.
次要结局
未报告次要终点
研究者
研究点 (5)
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