Phase 3
N=44
Oral Ketorolac for Arthroscopic Rotator Cuff Repair
Rotator Cuff Tear · Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT03967847 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Postoperative Visual Analog Scale Scores — 30; 20 score/units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ketorolac (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospitals Cleveland Medical Center
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Visual Analog Scale Scores |
30; 20 | — |
| SECONDARY Number of Participants With Retear of Rotator Cuff Repair |
3; 2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients between the ages of 18 and 89 years old, male or female
- Patients undergoing primary shoulder arthroscopic rotator cuff repair
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03967847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.