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

NCT02152163 | Completed Phase 4 Results DMC

• 1 other identifier: WIRB Protocol #20121749
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

STUDY OBJECTIVES:

1. 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. 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.

Conditions

Pain

Keywords

Ibuprofen; Caldolor; orthopedic trauma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

IV Ibuprofen 800 mg

ACTIVE COMPARATOR

IV Ibuprofen 800 mg

Drug: IV Ibuprofen

IV Saline

PLACEBO COMPARATOR

IV Saline

Drug: placebo

Interventions

IV Ibuprofen DRUG

Also known as: IV Caldolor

IV Ibuprofen 800 mg

placebo DRUG

Also known as: iv saline

IV Saline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Trauma patient admitted to Trauma ICU or Trauma Step-Down Units.
• Fracture of ribs, face, extremities and/or pelvis
• Age between 18 and 75 years old
• Adequate IV access
• Able to self report and communicate pain severity

You may not qualify if:

• History of allergy or hypersensitivity to any component of IV Ibuprofen, aspirin (or aspirin related products) NSAIDs, or COX-2 inhibitors
• Any intracranial or spinal cord trauma
• History of clinically significant bleeding disorders including ITP, DIC or platelet dysfunction
• Recent history of intracranial surgery or stroke (within past 30 days)
• History of ulcers, gastritis or previous GI bleeding
• Renal Impairment (Creatinine \> 3.0 mg/dL)
• Pregnant or breastfeeding
• Otherwise unsuitable in the opinion of the treating physician at time of randomization.

Sponsors & Collaborators

• Delray Medical Center: lead

Study Sites (1)

Delray Medical Center

Delray Beach, Florida, 33484, United States

Location

Related 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.

  PMID: 24165259 BACKGROUND

• 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.

  PMID: 16481924 BACKGROUND

• 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.

  PMID: 31929374 RESULT

MeSH Terms

Conditions

Pain

Interventions

Ibuprofen; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Russell Weisz, MD
• Organization: Delray Medical Center

rdweisz@gmail.com

561-213-9371

Study Officials

• Russell Weisz, MD

  Delray Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Staff, including the principal investigator, study coordinator, and trauma nurses and the patients were blinded as to the treatment they received. In order to maintain the double-blind protocol, all IV bags had identical appearance and label.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: , randomized, double-blind, parallel-group, placebo-controlled study. Eligible patients who signed the informed consent were randomized to either IV Ibuprofen (Caldolor®) or Placebo via a computer-generated randomization list.

Study Record Dates

• First Submitted: May 16, 2014
• First Posted: June 2, 2014
• Study Start: October 1, 2012
• Primary Completion: April 1, 2017
• Study Completion: February 1, 2018
• Last Updated: July 12, 2021
• Results First Posted: July 12, 2021

Record last verified: 2021-07

Locations

US (1)