A Pilot Study to Determine the Efficacy of Intravenous Ibuprofen for Pain Control Following Arthroscopic Knee Surgery
Overview
- Phase
- Phase 4
- Intervention
- IV ibuprofen
- Conditions
- Arthroscopic Knee Surgery
- Sponsor
- Cumberland Pharmaceuticals
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Efficacy of IV Ibuprofen for Post-op Pain.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
Detailed Description
Non-steroidal anti-inflammatory drugs(NSAIDs) are an effective adjunct to opioid analgesia for moderate-severe pain, with improvement in the quality of pain relief and consistent evidence of opioid dose sparing. NSAIDs alone could provide effective analgesia post-surgery when mild-moderate pain is expected. There is also evidence that the use of NSAIDs, by avoiding or decreasing the need for opioids, can lead to a reduction in the incidence of adverse events which are commonly attributed to, or exacerbated by, opioids. 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.
Investigators
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.
Arms & Interventions
IV ibuprofen
Intravenous ibuprofen (800 mg) administered intravenously over 10 minutes at study hour 0 and again at study hour 4 (Ibuprofen arm) and a corresponding volume of normal saline (ketorolac arm) will be administered intravenously over no less than 15 seconds at the end of the arthroscopic procedure
Intervention: IV ibuprofen
IV ketorolac
A corresponding volume of normal saline (Ibuprofen arm) administered intravenously over 10 minutes at study hour 0 and again at study hour 4 and 30 mg ketorolac for patients \< 65 years of age (15 mg ketorolac for patients \> 65 years of age) (ketorolac arm) will be administered intravenously over no less than 15 seconds at the end of the arthroscopic procedure
Intervention: IV ketorolac
Outcomes
Primary Outcomes
Efficacy of IV Ibuprofen for Post-op Pain.
Time Frame: first possible assessment following surgery
Measurement of the efficacy of IV ibuprofen for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS) upon first possible assessment following surgery. The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between o and 100.
Secondary Outcomes
- Time to Discharge.(24 hours)
- Incidence of Serious Adverse Events (SAEs).(24 hours)
- 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(24 hours)
- 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(24 Hours)
- 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(24 hours)
- Patient Satisfaction.(24 hours)