NCT01650519

A Pilot Study to Determine the Efficacy of Intravenous Ibuprofen for Pain Control Following Arthroscopic Knee Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Cumberland Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthroscopic Knee Surgery

Interventions

Type	Name	Description
DRUG	IV ibuprofen	800 mg intravenous ibuprofen administered intravenously over 10 minutes.
DRUG	IV ketorolac	30 mg ketorolac for patients \< 65 years of age (15 mg ketorolac for patients \> 65 years of age) administered intravenously over no less than 15 seconds

Timeline

• Start date: 2012-09-01
• Primary completion: 2012-12-01
• Completion: 2013-01-01
• First posted: 2012-07-26
• Last updated: 2016-06-23
• Results posted: 2014-07-10

Locations

1 site across 1 country: United States