Phase 4
N=100
Efficacy of Intravenous Ibuprofen Compared to Intravenous Ketorolac for Pain Control Following Arthroscopic Knee Surgery
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01901393 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Efficacy of Pain Relief (Pain Intensity at Rest) — 30; 32 units on a scale (in mm)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- IV ibuprofen (Drug); Ketorolac (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cumberland Pharmaceuticals
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of Pain Relief (Pain Intensity at Rest) |
30; 32 | — |
| PRIMARY Efficacy of Pain Relief (Pain Intensity With Movement) |
32; 41 | — |
| SECONDARY Rescue Medication Use in Post-operative Period |
13.7; 13.2; 188.5; 179.1 | — |
| SECONDARY Time to First Use of Rescue Med Will be Measured |
1.2; 1.2 | — |
| SECONDARY Patient Satisfaction |
0; 1; 4; 8; 20; 18 | — |
| SECONDARY Incidence of Serious Adverse Events |
0; 0 | — |
Summary
The purpose of this study is to assess the efficacy of intravenous ibuprofen compared to ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS)
Eligibility Criteria
Inclusion Criteria
- Patients scheduled for knee arthroscopy
Exclusion Criteria
- Inadequate IV access.
- History of allergy or hypersensitivity to any component of ibuprofen, ketorolac, aspirin (or aspirin related products), non-steroidal anti-inflammatory drugs (NSAIDs), opioids or cyclooxygenase-2 (COX-2) inhibitors.
- Less than 18 years of age.
- Use of analgesics less than 8 hours prior to surgery.
- Patients with active, clinically significant anemia.
- History or evidence of asthma or heart failure.
- Pregnant.
- Recent history of chronic opioid use.
- Concomitant use of probenecid.
- Inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]), and agree to abide by the study restrictions and to return for the required assessments.
- Refusal to provide written authorization for use and disclosure of protected health information.
Data sourced from ClinicalTrials.gov (NCT01901393). 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.