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

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: IV Ibuprofen; Drug: placebo

• Registration Number: NCT02152163
• Lead Sponsor: Delray Medical Center

Brief 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.

Detailed 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)

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2014-05-16
• Study First Submitted QC: 2014-05-30
• Study First Posted: 2014-06-02
• Primary Completion: 2017-04
• Study Completion: 2018-02
• Results First Submitted: 2021-02-08
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-08
• Last Update Submitted: 2021-07-08
• Results First Posted: 2021-07-12
• Last Update Posted: 2021-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV Ibuprofen 800 mg	IV Ibuprofen	IV Ibuprofen 800 mg
IV Saline	placebo	IV Saline

Primary Outcome Measures

Name	Time	Method
Efficacy of IV Ibuprofen in Orthropedic Trauma Patients	morphine equivalent dosage in over 48 hours after admission	Outcome measure based on morphine equivalent dosage comparing the two groups

Trial Locations

Locations (1)

Delray Medical Center; 🇺🇸 Delray Beach, Florida, United States