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 treatment of fever or pain in the hospital setting.

Official Title
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A Multi-Center, Open-Label, Surveillance Trial To Evaluate The Safety and Efficacy of a Shortened Infusion Time of Intravenous Ibuprofen.

Conditions
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Pain, Fever

Intervention / Treatment
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* Drug: Intravenous ibuprofen


Participation Criteria
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Eligibility Criteria
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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

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 (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. | Drug: Intravenous ibuprofen<br>* 400 mg or 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 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 | 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. | 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) | 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). | 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). | 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). | 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). | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | 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. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Fever