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

Delray Medical Center99 enrolled

Overview

STUDY OBJECTIVES: 1. 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. 2. 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.

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

TRIPLE

Enrollment

Conditions

Pain

Interventions

IV IbuprofenDRUG

placeboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Trauma patient admitted to Trauma ICU or Trauma Step-Down Units. 2. Fracture of ribs, face, extremities and/or pelvis 3. Age between 18 and 75 years old 4. Adequate IV access 5. Able to self report and communicate pain severity Exclusion Criteria: 1. History of allergy or hypersensitivity to any component of IV Ibuprofen, aspirin (or aspirin related products) NSAIDs, or COX-2 inhibitors 2. Any intracranial or spinal cord trauma 3. History of clinically significant bleeding disorders including ITP, DIC or platelet dysfunction 4. Recent history of intracranial surgery or stroke (within past 30 days) 5. History of ulcers, gastritis or previous GI bleeding 6. Renal Impairment (Creatinine \> 3.0 mg/dL) 7. Pregnant or breastfeeding 8. Otherwise unsuitable in the opinion of the treating physician at time of randomization.

Locations (1)

Delray Medical Center

Delray Beach, Florida, United States

Outcomes

Primary Outcomes

Efficacy of IV Ibuprofen in Orthropedic Trauma Patients

Outcome measure based on morphine equivalent dosage comparing the two groups

Time frame: morphine equivalent dosage in over 48 hours after admission

Data from ClinicalTrials.gov

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