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CompletedNCT03967847Updated May 10, 2022Results posted

Oral Ketorolac for Arthroscopic Rotator Cuff Repair

A Phase 3 interventional study of Ketorolac in Rotator Cuff Tear and Postoperative Pain, sponsored by University Hospitals Cleveland Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2022-05-10.

Sponsored by University Hospitals Cleveland Medical Center · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Feb 2019, registered May 2019).
Phase
Phase 3
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 89 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Rotator Cuff Tear
  • Postoperative Pain

Keywords

  • Rotator Cuff Tear
  • Postoperative Pain
03

In context

Rotator Cuff Injuries

745 studies on the registry are indexed under Rotator Cuff Injuries; 163 are open to participants now.

This study's enrollment of 44 is below the median of 60 across 547 interventional studies indexed under Rotator Cuff Injuries.

Browse Rotator Cuff Injuries studies →

Lead sponsor

University Hospitals Cleveland Medical Center is the lead sponsor of 293 studies on the registry; 43 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 30 (86%) have results posted.

Browse University Hospitals Cleveland Medical Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • No intervention
    Control
  • Experimental
    Ketorolac

    Drug: Ketorolac

Interventions

06

What researchers measure

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.

    Time frame: participants were assessed at one single time point up to 8 weeks.

Secondary outcomes

  1. Number of Participants With Retear of Rotator Cuff Repair

    Assessing retear of rotator cuff repair on postop MRI.

    Time frame: 6 months

07

Results

Posted May 10, 2022

Participant flow

44 patients were enrolled/randomized but only 39 patients were included for final analysis because of incomplete data collection

Participant flow — Overall Study
MilestoneControlKetorolac
Started2123
Completed2123
Not completed00

Outcome measures

PrimaryPostoperative 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.

Time frame:
participants were assessed at one single time point up to 8 weeks.
Reported as:
Median · score/units on a scale
Postoperative Visual Analog Scale Scores
score/units on a scaleControlKetorolac
Postoperative Visual Analog Scale Scores30 (15 to 50)20 (8.75 to 32.5)
SecondaryNumber of Participants With Retear of Rotator Cuff Repair

Assessing retear of rotator cuff repair on postop MRI.

Time frame:
6 months
Reported as:
Count of participants · Participants
Number of Participants With Retear of Rotator Cuff Repair
ParticipantsControlKetorolac
Number of Participants With Retear of Rotator Cuff Repair32

Adverse events

Collected over 14 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Control0/19 (0%)0/19 (0%)16/19 (84.2%)
Ketorolac0/20 (0%)0/20 (0%)9/20 (45%)
Most frequent other events
Showing 10 of 11
Most frequent other events
EventControlKetorolac
DrowsinessNervous system disorders4/191/20
ConstipationGastrointestinal disorders3/190/20
DizzinessNervous system disorders3/190/20
Nausea/VomitingGastrointestinal disorders2/192/20
InsomniaNervous system disorders1/192/20
HeadacheNervous system disorders0/192/20
DiarrheaGastrointestinal disorders1/190/20
Dry mouthGastrointestinal disorders1/190/20
ItchingImmune system disorders1/190/20
Abdominal PainGastrointestinal disorders0/191/20

Baseline characteristics

44 patients were enrolled/randomized but only 39 patients were included for final analysis because of incomplete data collection

Age, Continuous
Age, Continuous(Years)ControlKetorolacTotal
Mean55.7 ± 12.955.7 ± 8.255.7 ± 10.5
Sex: Female, Male
Sex: Female, Male(Participants)ControlKetorolacTotal
Female8513
Male111526
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)ControlKetorolacTotal
White121527
Black7512
Hispanic000
Asian000
Other000
BMI
BMI(kg/m^2)ControlKetorolacTotal
Mean29.2 ± 6.132.9 ± 6.531 ± 6.3
Smoker
Smoker(Participants)ControlKetorolacTotal
Count of participants437
08

Study locations

1 site
  • University Hospitals Cleveland Medical Center
    Cleveland, Ohio 44106, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 19, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2019 to primary completion in Oct 2020, 20 months.

Results were first posted in May 2022, 1 year 6 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
May 27, 2019
First posted
May 30, 2019
StartActual
Feb 11, 2019
Primary completionActual
Oct 14, 2020
CompletionActual
May 17, 2021
Results first posted
May 10, 2022
Last update
May 10, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03967847
Lead sponsor
University Hospitals Cleveland Medical Center
Responsible party
Robert J. Gillespie (Principal Investigator, University Hospitals Cleveland Medical Center) — Principal investigator
First posted
May 30, 2019
Start date
Feb 11, 2019
Primary completion
Oct 14, 2020
Completion
May 17, 2021
Results posted
May 10, 2022
Last update
May 10, 2022

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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