Surgical Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-Center, Open-Label, Surgical Surveillance Trial To Evaluate The Safety And Efficacy Of A Shortened Infusion Time of Intravenous Ibuprofen

Conditions
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Pain

Intervention / Treatment
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* Drug: Intravenous ibuprofen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous ibuprofen<br>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. | Drug: Intravenous ibuprofen<br>* 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes<br>* Other names: Caldolor;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain. | The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen | 6 hours | 
| To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain. | The incidence of treatment-emergent adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen | 6 hours | 
| To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain. | 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. | 6 hours |