Pain
Conditions
Keywords
Ibuprofen, Caldolor, orthopedic trauma
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)
Interventions
DRUGIV Ibuprofen
DRUGplacebo
Sponsors
Delray Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Intervention model description
, 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IV Ibuprofen 800 mg IV Ibuprofen 800 mg
IV Ibuprofen | 39 |
| IV Saline IV Saline
placebo | 35 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 12 | 13 |
Baseline characteristics
| Characteristic | IV Saline | Total | IV Ibuprofen 800 mg |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 74 Participants | 39 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 35 Participants | 74 Participants | 39 Participants |
| Sex: Female, Male Female | 7 Participants | 16 Participants | 9 Participants |
| Sex: Female, Male Male | 28 Participants | 58 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 35 |
| other Total, other adverse events | 0 / 39 | 0 / 35 |
| serious Total, serious adverse events | 0 / 39 | 0 / 35 |
Outcome results
Primary
Efficacy of IV Ibuprofen in Orthropedic Trauma Patients
Outcome measure based on morphine equivalent dosage comparing the two groups
Time frame: morphine equivalent dosage in over 48 hours after admission
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| IV Ibuprofen 800 mg | Efficacy of IV Ibuprofen in Orthropedic Trauma Patients | 74.9 morphine equivalent dosage, mg |
| IV Saline | Efficacy of IV Ibuprofen in Orthropedic Trauma Patients | 97.8 morphine equivalent dosage, mg |