Burns
Conditions
Brief summary
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.
Interventions
DRUGCaldolor
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
DRUGPlacebo
Placebo
Sponsors
Cumberland Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Adequate intravenous access 3. Have fever, documented by temperature greater than or equal to 38.0 degree celsius (100.4 degree fahrenheit)
Exclusion criteria
1. Patients with electric burns 2. Use of acetaminophen, non-steriodal anti-inflammatory agents (NSAIDs) or other fever reducing medications within 4 hours prior to dosing 3. Patients taking warfarin or lithium 4. Active, clinically significant asthma 5. History of allergy or hypersensitivity to any component of intravenous ibuprofen, NSAIDs, aspirin (or related products), or COX-2 inhibitors 6. Pregnant or nursing 7. 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 8. 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 9. Have gastrointestional bleeding that required medical intervention within the previous 6 weeks (unless definitive surgery has been performed) 10. Have a platelet count less than 20,000 mm\^3 11. Be on dialysis 12. Be receiving full dose anticoagulation therapy or Activated Protein C within 6 hours before dosing (clopidogrel, prophylaxis with enoxaparin or subcutaneous heparin is acceptable) 13. 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.) 14. 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.) 15. Have received another investigational drug within the past 30 days 16. Be otherwise unsuitable for the study in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Temperature | 0 to 24 hours | Area under the curve temperature from baseline to hour 24 following initiation of treatment. |
Countries
India, United States
Participant flow
Recruitment details
Participants were patients admitted to the study centers who had second and third degree thermal burns covering more than 10% total body surface area, including the face.
Participants by arm
| Arm | Count |
|---|---|
| Placebo (250 Milliliters Normal Saline) | 21 |
| 800mg Intravenous Ibuprofen | 40 |
| Total | 61 |
Baseline characteristics
| Characteristic | Placebo (250 Milliliters Normal Saline) | 800mg Intravenous Ibuprofen | Total |
|---|---|---|---|
| Age Continuous | 30 years STANDARD_DEVIATION 11.9 | 33 years STANDARD_DEVIATION 10.8 | 32 years STANDARD_DEVIATION 11.2 |
| Age, Customized <=12 years old | 0 participants | 0 participants | 0 participants |
| Age, Customized >12 years old | 21 participants | 40 participants | 61 participants |
| Region of Enrollment India | 14 participants | 31 participants | 45 participants |
| Region of Enrollment United States | 7 participants | 9 participants | 16 participants |
| Sex: Female, Male Female | 11 Participants | 25 Participants | 36 Participants |
| Sex: Female, Male Male | 10 Participants | 15 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 21 | 23 / 40 |
| serious Total, serious adverse events | 3 / 21 | 5 / 40 |
Outcome results
Primary
Temperature
Area under the curve temperature from baseline to hour 24 following initiation of treatment.
Time frame: 0 to 24 hours
Population: Efficacy analyses were performed on the Intent to Treat (ITT) population and the Efficacy Evaluable Population (EEP). All randomized patients who received at least a partial dose of CTM were included in the ITT analyses. All data below represents the ITT analyses.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (250 Milliliters Normal Saline) | Temperature | 18.29 Degree Celcius times hours (AUC-T) | Standard Error 2.2 |
| 800mg Intravenous Ibuprofen | Temperature | 12.21 Degree Celcius times hours (AUC-T) | Standard Error 1.7 |