Surgical 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 preemptive treatment of postoperative pain.

Recruitment & Eligibility

Inclusion Criteria

Patients scheduled for surgery with anticipated need for postoperative analgesia

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

Primary Outcome Measures

Name	Time	Method
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.	6 hours	The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.	6 hours	The incidence of treatment-emergent adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen

Secondary Outcome Measures

Name	Time	Method
To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.	6 hours	The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen
To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.	6 hours	Visual Analog Scale (VAS) assessments following surgery. 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.

Locations (22): UC San Diego Regional Center
🇺🇸
La Jolla, California, United States
Neurovations (Queen of the Valley Hospital)
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Napa, California, United States
University of Miami Health System
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Miami, Florida, United States
Sheridan Clinical Research
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Plantation, Florida, United States
RUSH Univ. Medical Center
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Chicago, Illinois, United States
Univ. of Kansas Medical Center
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Kansas City, Kansas, United States
Ochsner Medical Center
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New Orleans, Louisiana, United States
Brigham and Women's Hospital
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Boston, Massachusetts, United States
Detroit Medical Center
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Detroit, Michigan, United States
North Mississippi Sports Medicine & Orthopaedic Clinic
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Tupelo, Mississippi, United States
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UC San Diego Regional Center
🇺🇸La Jolla, California, United States