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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: placebo; Drug: IV Ibuprofen

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 Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Delray Beach, Florida, United States, 33484
      • Delray Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IV Ibuprofen 800 mg	Drug: IV Ibuprofen; Other Names: IV Caldolor
Placebo Comparator: IV Saline	Drug: placebo; Other Names: iv saline

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Delray Medical Center
• Investigators: Principal Investigator: Russell Weisz, MD, Delray Medical Center

Publications and helpful links

General Publications

• Bayouth L, Safcsak K, Cheatham ML, Smith CP, Birrer KL, Promes JT. Early intravenous ibuprofen decreases narcotic requirement and length of stay after traumatic rib fracture. Am Surg. 2013 Nov;79(11):1207-12.
• Drendel AL, Lyon R, Bergholte J, Kim MK. Outpatient pediatric pain management practices for fractures. Pediatr Emerg Care. 2006 Feb;22(2):94-9. doi: 10.1097/01.pec.0000199564.64264.f4.
• Weisz RD, Fokin AA, Lerner V, Flynt A, Macias-Perez I, Pavliv L, Crawford M, Puente I. Intravenous Ibuprofen Reduces Opioid Consumption During the Initial 48 Hours After Injury in Orthopedic Trauma Patients. J Orthop Trauma. 2020 Jul;34(7):341-347. doi: 10.1097/BOT.0000000000001733.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: May 16, 2014
• First Submitted That Met QC Criteria: May 30, 2014
• First Posted (Estimate): June 2, 2014

Study Record Updates

• Last Update Posted (Actual): July 12, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Ibuprofen; Caldolor; orthopedic trauma
• Additional Relevant MeSH Terms: Wounds and Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: WIRB Protocol #20121749