Overview

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

Status:
Completed

Trial end date:
2018-02-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Delray Medical Center

Treatments:

Ibuprofen

Criteria

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.