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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 61

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	-
2	Caldolor	-

Primary Outcome Measures

Name	Time	Method
Temperature	0 to 24 hours	Area under the curve temperature from baseline to hour 24 following initiation of treatment.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (5): Orlando Regional Medical Center
🇺🇸
Orlando, Florida, United States
Surya Hospitals Pvt. Ltd
🇮🇳
Pune, India
Naik's Hospital
🇮🇳
Baroda, Kothi, India
Wake Forest University Health Sciences
🇺🇸
Winston-Salem, North Carolina, United States
Lokmanya Tilak Municipal Medical College
🇮🇳
Mumbai, Sion, India