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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Cumberland Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01901393
First received: July 12, 2013
Last updated: February 3, 2014
Last verified: February 2014
  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 [ 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)


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 med (in mg) 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 ]
  • 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 ]

Estimated Enrollment: 100
Study Start Date: July 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 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
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), NSAIDs, opioids or 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

Contacts
Contact: Amy Rock, PhD 6152550068 arock@cumberlandpharma.com
Contact: Byron Kaelin, RN 6152550068 bkaelin@cumberlandpharma.com

Locations
United States, Florida
Shrock Orthopedic Research Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact: Natalie Shrock, ARNP    954-626-3743    Natalie@shrockresearch.com   
Principal Investigator: Kevin B Shrock, MD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Mahendrakumar Shah, MD    312-942-1982    Mahendrakumar_Shah@rush.edu   
Principal Investigator: Bernard R Bach, Jr., MD         
United States, Mississippi
North Mississippi Sports Medicine & Orthopaedic Clinic Recruiting
Tupelo, Mississippi, United States, 38801
Contact: Tracy Inman, LPN    662-840-5856      
Principal Investigator: Stephen Southworth, MD         
United States, Ohio
The Ohio State University Vexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Andrew Otey    614-366-1943    Fernando.Arbona@osumc.edu   
Principal Investigator: Fernando Arbona, MD         
Sponsors and Collaborators
Cumberland Pharmaceuticals
Investigators
Study Director: Arthur P Wheeler, MD Cumberland Pharmaceuticals Inc.
  More Information

No publications provided

Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01901393     History of Changes
Other Study ID Numbers: CPI-CL-020
Study First Received: July 12, 2013
Last Updated: February 3, 2014
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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 28, 2014