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Efficacy of Intravenous Ibuprofen Compared to Intravenous Ketorolac for Pain Control Following Arthroscopic Knee Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01901393
First received: July 12, 2013
Last updated: February 12, 2016
Last verified: February 2016
  Purpose
The purpose of this study is to assess the efficacy of intravenous ibuprofen compared to ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS)

Condition Intervention Phase
Pain
Drug: IV ibuprofen
Drug: Ketorolac
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Prospective, Randomized, Double-blind Study to Determine the Efficacy of Intravenous Ibuprofen Compared to Intravenous Ketorolac for Pain Control Following Arthroscopic Knee Surgery

Resource links provided by NLM:


Further study details as provided by Cumberland Pharmaceuticals:

Primary Outcome Measures:
  • Efficacy of Pain Relief (Pain Intensity at Rest) [ Time Frame: First possible time post-surgery, an expected average of 6 hours ] [ Designated as safety issue: No ]
    Pain assessed using VAS (Visual Analog Scale, VAS). 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 0 (No Pain) and 100 (Worst Possible Pain).

  • Efficacy of Pain Relief (Pain Intensity With Movement) [ Time Frame: First possible time post-surgery, an expected average of 6 hours ] [ Designated as safety issue: No ]
    Pain assessed using VAS (Visual Analog Scale, VAS). 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 0 (No Pain) and 100 (Worst Possible Pain).


Secondary Outcome Measures:
  • Rescue Medication Use in Post-operative Period [ Time Frame: Post-operative period until discharge, an expected average of 6 hours ] [ Designated as safety issue: No ]
    Amount of rescue medication (in milligrams) will be measured

  • Time to First Use of Rescue Med Will be Measured [ Time Frame: Post-operative period until discharge, an expected average of 6 hours ] [ Designated as safety issue: No ]
    Time to first rescue medication (in hours) in the postoperative period through discharge.

  • Patient Satisfaction [ Time Frame: Post-operative period until discharge, an expected average of 6 hours ] [ Designated as safety issue: No ]
    Measured using 2 question, 4 point scale.

  • Incidence of Serious Adverse Events [ Time Frame: Post-operative period until discharge, an expected average of 6 hours ] [ Designated as safety issue: Yes ]
    Number of subjects experiencing treatment-emergent serious adverse events


Enrollment: 100
Study Start Date: July 2013
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV ibuprofen
800mg ibuprofen
Drug: IV ibuprofen
Other Name: Caldolor
Active Comparator: ketorolac
30mg ketorolac
Drug: Ketorolac
Other Name: Ketorolac Tromethamine

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for knee arthroscopy

Exclusion Criteria:

  • Inadequate IV access.
  • History of allergy or hypersensitivity to any component of ibuprofen, ketorolac, aspirin (or aspirin related products), non-steroidal anti-inflammatory drugs (NSAIDs), 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 opioid use.
  • Concomitant use of probenecid.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01901393

Locations
United States, Florida
Shrock Orthopedic Research
Fort Lauderdale, Florida, United States, 33316
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Mississippi
North Mississippi Sports Medicine & Orthopaedic Clinic
Tupelo, Mississippi, United States, 38801
United States, Ohio
The Ohio State University Vexner Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Cumberland Pharmaceuticals
Investigators
Study Director: Arthur P Wheeler, MD Cumberland Pharmaceuticals Inc.
  More Information

Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01901393     History of Changes
Other Study ID Numbers: CPI-CL-020 
Study First Received: July 12, 2013
Results First Received: January 18, 2016
Last Updated: February 12, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Cumberland Pharmaceuticals:
Post Operative Pain,
Pail relief

Additional relevant MeSH terms:
Ibuprofen
Ketorolac Tromethamine
Ketorolac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 02, 2016