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

Delray Medical Center

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: placebo; Drug: IV Ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT02152163

WIRB Protocol #20121749

Details and patient eligibility

About

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.

Full description

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)

Enrollment: 99 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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99 participants in 2 patient groups, including a placebo group

IV Ibuprofen 800 mg

Active Comparator group

Description:

IV Ibuprofen 800 mg

Treatment:

Drug: IV Ibuprofen

IV Saline

Placebo Comparator group

Description:

IV Saline

Treatment:

Drug: placebo