Phase 4
N=99
Assessing the Efficacy of IV Ibuprofen for Treatment of Pain in Orthopedic Trauma Patients
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02152163 ↗Enrolled (actual)
99
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Efficacy of IV Ibuprofen in Orthropedic Trauma Patients — 74.9; 97.8 morphine equivalent dosage, mg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- IV Ibuprofen (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Delray Medical Center
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of IV Ibuprofen in Orthropedic Trauma Patients |
74.9; 97.8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02152163). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.