Phase 4
Completed N=51
A Pilot Study to Determine the Efficacy of Intravenous Ibuprofen for Pain Control Following Arthroscopic Knee Surgery
Arthroscopic Knee Surgery
Source: ClinicalTrials.gov NCT01650519 ↗
Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcomePrimary: Efficacy of IV Ibuprofen for Post-op Pain. — 8; 34; 19; 41 units on a scale
Summary
The intent of this study is to assess the analgesic efficacy of IV ibuprofen when administered at induction of anesthesia. Results from this pilot study will be used to design and determine the appropriate statistical power for a larger, multi-center randomized study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of IV Ibuprofen for Post-op Pain. |
8; 34; 19; 41 | — |
| SECONDARY Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Amount of Rescue Medication in the Postoperative Period Through Discharge |
5.4; 20.4; 162.5; 325 | — |
| SECONDARY Time to Discharge. |
1.8; 1.8 | — |
| SECONDARY Patient Satisfaction. |
20.2; 20.7; 28.3; 26.9; 30.5; 29.0 | — |
| SECONDARY Incidence of Serious Adverse Events (SAEs). |
0; 0 | — |
| SECONDARY Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Pain Intensity as Assess by Patient Pain Intensity (VAS) in the Post-surgical Period, Through 24 Hours |
4; 13; 12; 23 | — |
| SECONDARY Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Amount of Time to Rescue Medication in the Postoperative Period Through Discharge |
1.7; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Patients scheduled for knee arthroscopy
Exclusion Criteria
- Inadequate intravenous (IV) access.
- History of allergy or hypersensitivity to any component of ibuprofen or other NSAIDs, aspirin (or aspirin related products), 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 non-steroidal anti-inflammatory drug (NSAID) or opioid use.
- 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 (NCT01650519). 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. Informational only — not medical advice.