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

NCT ID: NCT01650519

Last Updated: 2016-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-01-31

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.

Conditions

Arthroscopic Knee Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

IV ibuprofen

Intervention Type: DRUG

800 mg intravenous ibuprofen administered intravenously over 10 minutes.

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

Group Type: ACTIVE_COMPARATOR

IV ketorolac

Intervention Type: DRUG

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

Interventions

IV ibuprofen

800 mg intravenous ibuprofen administered intravenously over 10 minutes.

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Caldolor; Toradol

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cumberland Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fernando L Arbona, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University, Wexner Medical Center

Columbus, Ohio, United States

Countries

United States

References

Uribe AA, Arbona FL, Flanigan DC, Kaeding CC, Palettas M, Bergese SD. Comparing the Efficacy of IV Ibuprofen and Ketorolac in the Management of Postoperative Pain Following Arthroscopic Knee Surgery. A Randomized Double-Blind Active Comparator Pilot Study. Front Surg. 2018 Oct 3;5:59. doi: 10.3389/fsurg.2018.00059. eCollection 2018.

Reference Type: DERIVED

PMID: 30338261 (View on PubMed)

Other Identifiers

CPI-CL-017

Identifier Type: -

Identifier Source: org_study_id