Efficacy and Safety Study of Caldolor (Intravenous Ibuprofen) in Hospitalized Adult and Pediatric Burn Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Double-blind, Placebo-Controlled Trial of Ibuprofen Injection (IVIb) for Treatment of Fever and Pain in Burn Patients

Conditions
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Burns

Intervention / Treatment
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* Drug: Caldolor
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: Placebo<br>* Placebo<br>|
| Experimental: 2<br> | Drug: Caldolor<br>* 800 milligrams of intravenous ibuprofen (patients greater 12 years of age) or 10 milligrams/kilograms (patients greater than 12 years; maximum of 400 milligrams) every 6 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temperature | Area under the curve temperature from baseline to hour 24 following initiation of treatment. | 0 to 24 hours |