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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02152163
• Other study ID #: WIRB Protocol #20121749
• Status: Completed
• Phase: Phase 4
• Start date: October 2012
• Est. completion date: February 2018

Study information

• Verified date: July 2021
• Source: Delray Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: February 2018
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain
• Wounds and Injuries

Intervention

Drug:
• IV Ibuprofen

• placebo

Locations

Country	Name	City	State
United States	Delray Medical Center	Delray Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Delray Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Drendel AL, Lyon R, Bergholte J, Kim MK. Outpatient pediatric pain management practices for fractures. Pediatr Emerg Care. 2006 Feb;22(2):94-9. — View Citation

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: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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