ACL InjuryPhase 3NCT04246554
Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic ACL Surgery
A Phase 3 study testing Ketorolac and Oxycodone-Acetaminophen in people with ACL Injury and Postoperative Pain, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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 ACL reconstruction surgery. 2. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- ACL Injury, Postoperative Pain
- What is being tested?
- Ketorolac and Oxycodone-Acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2019to 1 Jan 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between 18 and 89 years old
- Patients undergoing primary anterior cruciate ligament (ACL) reconstruction surgery
Who cannot join
- Patients below age 18 or above age 89
- Illiterate or non-English speaking individuals
- Patients with contraindications to Ketorolac
- History of chronic alcohol or drug abuse
- Chronic use of psychotropic or analgesic drugs
- Known peptic ulcer disease or bleeding diasthesis
Show all 9Show fewer
- Renal dysfunction (estimated glomerular filtration rate < 50 mL/min/1.73m2)
- Breastfeeding women
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
- 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 ACL reconstruction surgery.
- 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 ACL reconstruction surgery.
- Conditions
- ACL Injury, Postoperative Pain
- Being tested
- Ketorolac, Oxycodone-Acetaminophen
- Keywords
- ACL reconstruction, Ketorolac, Pain, Narcotic
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
Oral ketorolac for pain control following ACL reconstruction surgery
Oxycodone-AcetaminophenDrug
Oral oxycodone-acetaminophen for post-operative pain control
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Patients receive oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for pain following ACL reconstruction surgery Receives: Drug: Oxycodone-Acetaminophen |
| Ketorolac | Experimental | Patients receive IV ketorolac followed by ketorolac 10 mg every 6 hours for 3 days following ACL reconstruction surgery. Patients are additionally discharged with oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for additional pain control Receives: Drug: Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Visual Analogue Scale Scores
Patients will record their pain on a visual analogue scale with a minimum score of 0 and a maximum score of 100 where lower values indicate a lower pain level, and higher values indicate a higher pain level.
Measured: Up to 8 weeks postoperative
Secondary outcomes (1)
Narcotic Medication
Number of oxycodone-acetaminophen tablets
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start21 May 2019
- Primary completion9 Oct 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Karns, MD., University Hospitals Cleveland Medical Center
- Investigators
- Michael Karns, MD, Principal investigator, University Hospital Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246554
- Sponsor's protocol ID
- STUDY20180985
- Status last verified
- Nov 2021
- First submitted
- 24 Jan 2020
- Last updated
- 21 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Mengers SR, Strony JT, Sivasundaram L, Yu J, Goodfellow D, Salata MJ, Voos JE, Karns MR. Oral Ketorolac as an Adjuvant Agent for Postoperative Pain Control After Arthroscopic Anterior Cruciate Ligament Reconstruction: A Prospective, Randomized Controlled Study. J Am Acad Orthop Surg. 2022 Dec 15;30(24):e1580-e1590. doi: 10.5435/JAAOS-D-21-00721.
PubMed 36476466
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic ACL Surgery
- ClinicalTrials.gov ID
- NCT04246554
- Acronym / sponsor ID
- STUDY20180985
- Conditions
- ACL Injury, Postoperative Pain
- Keywords
- ACL reconstruction, Ketorolac, Pain, Narcotic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 21 May 2019 (actual)
- Primary completion
- 9 Oct 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 29 Jan 2020 (actual)
- Results
- Posted 21 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 ACL reconstruction surgery.
- 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 ACL reconstruction surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Drug: Oxycodone-AcetaminophenPatients receive oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for pain following ACL reconstruction surgery |
| Ketorolac | Experimental | Drug: KetorolacPatients receive IV ketorolac followed by ketorolac 10 mg every 6 hours for 3 days following ACL reconstruction surgery. Patients are additionally discharged with oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for additional pain control |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients between 18 and 89 years old
- Patients undergoing primary anterior cruciate ligament (ACL) reconstruction surgery
Key exclusion criteria (9 listed)
- Patients below age 18 or above age 89
- Illiterate or non-English speaking individuals
- Patients with contraindications to Ketorolac
- History of chronic alcohol or drug abuse
- Chronic use of psychotropic or analgesic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetorolacOral ketorolac for pain control following ACL reconstruction surgery | Drug | Ketorolac |
| Oxycodone-AcetaminophenOral oxycodone-acetaminophen for post-operative pain control | Drug | Control |
Primary outcome
Postoperative Visual Analogue Scale Scores
Time frame: Up to 8 weeks postoperative
Patients will record their pain on a visual analogue scale with a minimum score of 0 and a maximum score of 100 where lower values indicate a lower pain level, and higher values indicate a higher pain level.
1 secondary outcome
Narcotic Medication
Time frame: 5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36476466Mengers SR, Strony JT, Sivasundaram L, Yu J, Goodfellow D, Salata MJ, Voos JE, Karns MR. Oral Ketorolac as an Adjuvant Agent for Postoperative Pain Control After Arthroscopic Anterior Cruciate Ligament Reconstruction: A Prospective, Randomized Controlled Study. J Am Acad Orthop Surg. 2022 Dec 15;30(24):e1580-e1590. doi: 10.5435/JAAOS-D-21-00721.
Related trials for ACL Injury
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Karns, MD principal investigator
University Hospital Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketorolac and Oxycodone-Acetaminophen in people with ACL Injury and Postoperative Pain, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Visual Analogue Scale Scores (time frame: Up to 8 weeks postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04246554, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.