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

NCT01650519 | Completed Phase 4 Results

• 1 other identifier: CPI-CL-017
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroscopic Knee Surgery

Keywords

knee surgery, arthroscopy; orthopaedic, orthopedic surgery

Outcome Measures

Primary Outcomes (1)

• Efficacy of IV Ibuprofen for Post-op Pain.

  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.

  first possible assessment following surgery

Secondary Outcomes (6)

• 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

• Time to Discharge.

  24 hours

• Patient Satisfaction.

  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 Pain Intensity as Assess by Patient Pain Intensity (VAS) in the Post-surgical Period, Through 24 Hours

  24 Hours

Study Arms (2)

IV ibuprofen

ACTIVE COMPARATOR

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

Drug: IV ibuprofen

IV ketorolac

ACTIVE COMPARATOR

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

Drug: IV ketorolac

Interventions

IV ibuprofen DRUG

800 mg intravenous ibuprofen administered intravenously over 10 minutes.

Also known as: Caldolor

IV ibuprofen

IV ketorolac 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

Also known as: Toradol

IV ketorolac

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for knee arthroscopy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cumberland Pharmaceuticals: lead

Study Sites (1)

The Ohio State University, Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• 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.

  PMID: 30338261 DERIVED

MeSH Terms

Interventions

Ibuprofen; Ketorolac; Ketorolac Tromethamine

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Amy Rock, PhD
• Organization: Cumberland Pharmaceutical Inc.

arock@cumberlandpharma.com

615-255-0068

Study Officials

• Fernando L Arbona, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: July 26, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: June 23, 2016
• Results First Posted: July 10, 2014

Record last verified: 2016-05

Locations

US (1)