Oral Ketorolac for Arthroscopic Rotator Cuff Repair
Oral Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Rotator Cuff Repair
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 11, 2019
CompletedFirst Submitted
Initial submission to the registry
May 27, 2019
CompletedFirst Posted
Study publicly available on registry
May 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2021
CompletedResults Posted
Study results publicly available
May 10, 2022
CompletedMay 10, 2022
April 1, 2022
1.7 years
May 27, 2019
November 3, 2021
April 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative Visual Analog Scale Scores
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.
participants were assessed at one single time point up to 8 weeks.
Secondary Outcomes (1)
Number of Participants With Retear of Rotator Cuff Repair
6 months
Study Arms (2)
Control
NO INTERVENTIONKetorolac
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients between the ages of 18 and 89 years old, male or female
- Patients undergoing primary shoulder arthroscopic rotator cuff repair
You may not qualify if:
- Patients below the age of 18 or above the age of 89
- Illiterate or non-English speaking patients
- Patients with contraindications to Ketorolac
- History of alcohol of drug abuse
- Chronic use of analgesic or psychotropic drugs
- Known peptic ulcer disease or bleeding diathesis
- Renal dysfunction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John Strony, MD
- Organization
- University Hospitals Cleveland Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 27, 2019
First Posted
May 30, 2019
Study Start
February 11, 2019
Primary Completion
October 14, 2020
Study Completion
May 17, 2021
Last Updated
May 10, 2022
Results First Posted
May 10, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share