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Oral Ketorolac for Arthroscopic Rotator Cuff Repair

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ClinicalTrials.gov Identifier: NCT03967847
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Robert J. Gillespie, University Hospitals Cleveland Medical Center

Brief Summary:
  1. The investigators aim to examine the use of IV and oral ketorolac as an adjunctive agent to the standard of care pain protocol for postoperative pain control following arthroscopic rotator cuff repair.
  2. The investigators hypothesize that the use of IV and oral ketorolac in addition to the standard of care pain protocol will reduce postoperative opioid consumption following arthroscopic rotator cuff repair.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Postoperative Pain Drug: Ketorolac Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oral Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Rotator Cuff Repair
Actual Study Start Date : February 11, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ketorolac

Arm Intervention/treatment
No Intervention: Control
Experimental: Ketorolac Drug: Ketorolac
Oral Ketorolac




Primary Outcome Measures :
  1. Postoperative Visual Analog Scale Scores [ Time Frame: Up to 8 weeks postoperative ]
    The Visual Analog Scale ranges from a minimum score of 0 to a maximum score of 100. A smaller score would be considered a better outcome.



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Patients between the ages of 18 and 89 years old, male or female
  2. Patients undergoing primary shoulder arthroscopic rotator cuff repair

Exclusion Criteria

  1. Patients below the age of 18 or above the age of 89
  2. Illiterate or non-English speaking patients
  3. Patients with contraindications to Ketorolac
  4. History of alcohol of drug abuse
  5. Chronic use of analgesic or psychotropic drugs
  6. Known peptic ulcer disease or bleeding diathesis
  7. Renal dysfunction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03967847


Contacts
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Contact: Lakshmanan Sivasundaram, MD 2168443233 lakshmanan.sivasundaram@uhhospitals.org

Locations
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United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Lakshmanan Sivasundaram         
Sponsors and Collaborators
University Hospitals Cleveland Medical Center

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Responsible Party: Robert J. Gillespie, Principal Investigator, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT03967847     History of Changes
Other Study ID Numbers: 20180949
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Robert J. Gillespie, University Hospitals Cleveland Medical Center:
Rotator Cuff Tear
Postoperative Pain
Additional relevant MeSH terms:
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Ketorolac
Ketorolac Tromethamine
Pain, Postoperative
Rotator Cuff Injuries
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
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