The primary objective of this study is to determine the safety of a single dose of intravenous ibuprofen administered over 5-10 minutes for the treatment of fever or pain in the hospital setting.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes
UCSD
San Diego, California, United States
Danbury
Danbury, Connecticut, United States
University of Miami - Miller School of Medicine
Miami, Florida, United States
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.
The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen
Time frame: 6 hours
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.
The incidence of treatment-emergent adverse events occurring in the six hours following administration of intravenous ibuprofen.
Time frame: 6 hours
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting
The change from baseline to one hour post administration of intravenous ibuprofen in vitals sign assessments (Temperature)
Time frame: 1 hour
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.
The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Heart Rate).
Time frame: 1 hour
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.
The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Respiratory Rate).
Time frame: 1 hour
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.
The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Systolic Blood Pressure).
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Grady
Atlanta, Georgia, United States
Beth Israel Deaconnes MC
Boston, Massachusetts, United States
Columbia
New York, New York, United States
The University of North Carolina Hospitals
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
The Moses H. Cone Memorial Hospital
Greensboro, North Carolina, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
...and 3 more locations
Time frame: 1 hour
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.
The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Diastolic Blood Pressure).
Time frame: 1 hour
To Determine the Efficacy of a Single Dose of 400 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever
The change in temperature from baseline over the 4 hours following intravenous ibuprofen administration
Time frame: 4 hours
To Determine the Efficacy of a Single Dose of 800 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Pain (Mild to Moderate or Moderate to Severe).
The change in patient self-assessment of pain utilizing the visual analog scale (VAS) from baseline over the 4 hours following intravenous ibuprofen administration. The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between o and 100.
Time frame: 4 hours
To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain
The incidence of treatment-emergent serious adverse events occurring through extended dosing.
Time frame: 24 hours
To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain
The incidence of treatment-emergent adverse events occurring through extended dosing.
Time frame: 24 hours