Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen

Phase 4

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Pain: Patients with baseline Visual Analog Scale assessment >3, -and/or- Fever: Patients with temperature >101°F.

Exclusion Criteria

Patients with inadequate IV access
Patients <18 years of age
History or allergy or hypersensitivity to any component of intravenous ibuprofen, aspirin (or aspirin related products) or non-steroidal anti-inflammatory drug (NSAIDs)
Active hemorrhage or clinically significant bleeding
Pregnant or nursing
Patients in the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery
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
Refusal to provide written authorization for use and disclosure of protected health information

Arm && Interventions

Group	Intervention	Description
Intravenous ibuprofen	Intravenous ibuprofen	Intravenous ibuprofen (400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.

Primary Outcome Measures

Name	Time	Method
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.	1 hour	The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Diastolic Blood Pressure).
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	1 hour	The change from baseline to one hour post administration of intravenous ibuprofen in vitals sign assessments (Temperature)

Secondary Outcome Measures

Name	Time	Method
To Determine the Efficacy of a Single Dose of 400 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever	4 hours	The change in temperature from baseline over the 4 hours following intravenous ibuprofen administration
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).	4 hours	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.
To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain	24 hours	The incidence of treatment-emergent adverse events occurring through extended dosing.

Locations (13): Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
UCSD
🇺🇸
San Diego, California, United States
The Moses H. Cone Memorial Hospital
🇺🇸
Greensboro, North Carolina, United States
Grady
🇺🇸
Atlanta, Georgia, United States
University of Miami - Miller School of Medicine
🇺🇸
Miami, Florida, United States
Columbia
🇺🇸
New York, New York, United States
Lankenau
🇺🇸
Wynnewood, Pennsylvania, United States
Beth Israel Deaconnes MC
🇺🇸
Boston, Massachusetts, United States
The Ohio State University Medical Center
🇺🇸
Columbus, Ohio, United States
Fairview
🇺🇸
Cleveland, Ohio, United States
The University of North Carolina Hospitals
🇺🇸
Chapel Hill, North Carolina, United States
Wake Forest University Baptist Medical Center
🇺🇸
Winston-Salem, North Carolina, United States
Danbury
🇺🇸
Danbury, Connecticut, United States