Assessing the Efficacy of IV Ibuprofen for Treatment of Pain in Orthopedic Trauma Patients

Study Overview
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Brief Summary
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STUDY OBJECTIVES: To evaluate the effectiveness of around the clock (OTC) IV ibuprofen (8 doses) in decreasing pain in orthopedic trauma patients with fractures of the extremities, face, pelvis and/or ribs compared to patients not receiving the medication. To evaluate the effectiveness of around the clock (OTC) IV ibuprofen (8 doses) in decreasing the use of opioid analgesics among orthopedic trauma patients with fractures of the extremities, face, pelvis, and/or ribs compared to compared to patients not receiving the medication.

Detailed Description
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Eligible patients were trauma patients between the ages of 18 and 75 years old with adequate IV access who were able to self-report and communicate pain severity and who were consecutively admitted to the trauma intensive care unit (ICU) or trauma step-down units with a fracture of the ribs, face, extremities and/or pelvis. Eligible patients who signed the informed consent were randomized to either IV Ibuprofen (Caldolor®) or Placebo via a computer-generated randomization list. Patients had pain measured using a Numerical Rating Scale (NRS) that ranged from 0 (no pain) to 10 (worst possible pain)

Official Title
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Assessing the Efficacy of IV Ibuprofen for Treatment of Pain in Orthopedic Trauma Patients

Conditions
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Pain

Intervention / Treatment
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* Drug: IV Ibuprofen
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Trauma patient admitted to Trauma ICU or Trauma Step-Down Units. Fracture of ribs, face, extremities and/or pelvis Age between 18 and 75 years old Adequate IV access Able to self report and communicate pain severity Exclusion Criteria: History of allergy or hypersensitivity to any component of IV Ibuprofen, aspirin (or aspirin related products) NSAIDs, or COX-2 inhibitors Any intracranial or spinal cord trauma History of clinically significant bleeding disorders including ITP, DIC or platelet dysfunction Recent history of intracranial surgery or stroke (within past 30 days) History of ulcers, gastritis or previous GI bleeding Renal Impairment (Creatinine > 3.0 mg/dL) Pregnant or breastfeeding Otherwise unsuitable in the opinion of the treating physician at time of randomization.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: , randomized, double-blind, parallel-group, placebo-controlled study. Eligible patients who signed the informed consent were randomized to either IV Ibuprofen (Caldolor®) or Placebo via a computer-generated randomization list.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IV Ibuprofen 800 mg<br>IV Ibuprofen 800 mg | Drug: IV Ibuprofen<br> <br> * Other names: IV Caldolor;|
| Placebo Comparator: IV Saline<br>IV Saline | Drug: placebo<br> <br> * Other names: iv saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of IV Ibuprofen in Orthropedic Trauma Patients | Outcome measure based on morphine equivalent dosage comparing the two groups | morphine equivalent dosage in over 48 hours after admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ibuprofen, Caldolor, orthopedic trauma