Kidney CalculiPhase 4SKOPENCT03888144
Study of Ketorolac Versus Opioid for Pain After Endoscopy
A Phase 4 study testing Oxycodone and Ketorolac in people with Kidney Calculi and Ureteral Calculi, run by The Cleveland Clinic at 1 site in United States.
Trial summary
A double blind randomized controlled trial designed to compare pain control and safety with ketorolac and oxycodone in the post-operative setting for patients undergoing ureteroscopy for treatment of urinary stones. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Calculi, Ureteral Calculi
- What is being tested?
- Oxycodone and Ketorolac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2017to 1 Aug 2021
- Phase
- Phase 4
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with kidney or ureteral stones confirmed on imaging (CT of the abdomen pelvis) and who elect for definitive treatment via unilateral ureteroscopy at one of two hospital sites within a tertiary care institution
- Patients who post-operatively receive a unilateral ureteral stent
- Capable of giving informed consent
- Capable and willing to fulfill requirements of the study
Who cannot join
- Active or history of peptic ulcer disease, gastrointestinal bleeding or perforation
- History of coronary artery bypass graft surgery
- History of a bleeding disorder
- GFR less than 60 mL/min/1.73m2 (MDRD equation)
- Chronic use of opioid or other pain medication including NSAIDs (greater than 12 weeks)
- Known allergy to either ketorolac or oxycodone
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- Known or suspected pregnancy
- Solitary kidney
- Patients taking anticoagulant medication or antiplatelet medication (e.g. warfarin, clopidogrel, pradaxa, rivaroxaban, apixaban etc).
- Inability to give informed consent or unable to meet requirements of the study for any reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Ketorolac Versus Opioid for Pain After Endoscopy (SKOPE): A Double-blinded Randomized Control Trial Comparing Outpatient Analgesic Efficacy of NSAIDs and Opioids in Patients Undergoing Ureteroscopy for Kidney Stones
A double blind randomized controlled trial designed to compare pain control and safety with ketorolac and oxycodone in the post-operative setting for patients undergoing ureteroscopy for treatment of urinary stones. Patients are followed for five days after their surgery as they record their pain scores, medication utilization, and stent related symptoms.
Read the detailed description
Pain is the leading cause for unplanned emergency department visits and readmissions after ureteroscopy (URS), making post-operative analgesic stewardship a priority given the current opioid epidemic. The investigators conducted a double-blinded, randomized controlled trial (RCT), with non-inferiority design, comparing nonsteroidal anti-inflammatory drugs (NSAIDs) to opiates for postoperative pain control in patients undergoing URS for urolithiasis.
Patients were randomized and blinded to either oxycodone (5mg) or ketorolac (10mg), taken as needed, with 3 non-blinded oxycodone rescue pills for breakthrough pain. Primary study outcome was visual analog scale pain score on post-operative days 1-5. Secondary outcomes included medication utilization, side effects, and Ureteral Stent Symptoms Questionnaire (USSQ) scores.
- Conditions
- Kidney Calculi, Ureteral Calculi
- Medical subject headings
- Kidney Calculi, Ureteral Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
5 mg of oxycodone taken by mouth every 6 hours for 5 days
KetorolacDrug
Also called Toradol
10 mg of ketorolac taken by mouth every 6 hours for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone group | Active comparator | Patients randomized to 20 pills of 5 mg oxycodone by mouth every 6 hours as needed for pain after ureteroscopy. Receives: Drug: Oxycodone |
| Ketorolac group | Experimental | Patients randomized to 20 pills of 10 mg ketorolac by mouth every 6 hours as needed for pain after ureteroscopy. Receives: Drug: Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Pain Score
Patient Reported Visual Analogue Score scored from 0-10 with lower scores equaling less pain.
Measured: 5 days
Secondary outcomes (2)
Number of Study Pills Used
the use of opioid medication as per the study protocol; Required study pills
Measured: Post-operative days 1 to 5
Use of Rescue Medication (Opioid)
the use of rescue opioid medication as per the study protocol; use of rescue medication by the patients
Measured: post operative day 1-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start13 Oct 2017
- Primary completion1 Aug 2021
- Study completion1 Aug 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.
- Other trials for Kidney CalculiStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sriharan Sivalingam, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888144
- Sponsor's protocol ID
- 17-872
- Acronym
- SKOPE
- Status last verified
- Dec 2025
- First submitted
- 14 Mar 2019
- Last updated
- 23 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Ketorolac Versus Opioid for Pain After Endoscopy (SKOPE): A Double-blinded Randomized Control Trial Comparing Outpatient Analgesic Efficacy of NSAIDs and Opioids in Patients Undergoing Ureteroscopy for Kidney Stones
- ClinicalTrials.gov ID
- NCT03888144
- Acronym / sponsor ID
- SKOPE / 17-872
- Conditions
- Kidney Calculi, Ureteral Calculi
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 13 Oct 2017 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 25 Mar 2019 (actual)
- Results
- Posted 23 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A double blind randomized controlled trial designed to compare pain control and safety with ketorolac and oxycodone in the post-operative setting for patients undergoing ureteroscopy for treatment of urinary stones. Patients are followed for five days after their surgery as they record their pain scores, medication utilization, and stent related symptoms.
Detailed description
Pain is the leading cause for unplanned emergency department visits and readmissions after ureteroscopy (URS), making post-operative analgesic stewardship a priority given the current opioid epidemic. The investigators conducted a double-blinded, randomized controlled trial (RCT), with non-inferiority design, comparing nonsteroidal anti-inflammatory drugs (NSAIDs) to opiates for postoperative pain control in patients undergoing URS for urolithiasis.
Patients were randomized and blinded to either oxycodone (5mg) or ketorolac (10mg), taken as needed, with 3 non-blinded oxycodone rescue pills for breakthrough pain. Primary study outcome was visual analog scale pain score on post-operative days 1-5. Secondary outcomes included medication utilization, side effects, and Ureteral Stent Symptoms Questionnaire (USSQ) scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxycodone group | Active comparator | Drug: OxycodonePatients randomized to 20 pills of 5 mg oxycodone by mouth every 6 hours as needed for pain after ureteroscopy. |
| Ketorolac group | Experimental | Drug: KetorolacPatients randomized to 20 pills of 10 mg ketorolac by mouth every 6 hours as needed for pain after ureteroscopy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with kidney or ureteral stones confirmed on imaging (CT of the abdomen pelvis) and who elect for definitive treatment via unilateral ureteroscopy at one of two hospital sites within a tertiary care institution
- Patients who post-operatively receive a unilateral ureteral stent
- Capable of giving informed consent
- Capable and willing to fulfill requirements of the study
Key exclusion criteria (10 listed)
- Active or history of peptic ulcer disease, gastrointestinal bleeding or perforation
- History of coronary artery bypass graft surgery
- History of a bleeding disorder
- GFR less than 60 mL/min/1.73m2 (MDRD equation)
- Chronic use of opioid or other pain medication including NSAIDs (greater than 12 weeks)
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 |
|---|---|---|
| Oxycodone5 mg of oxycodone taken by mouth every 6 hours for 5 days | Drug | Oxycodone group |
| KetorolacAlso: Toradol10 mg of ketorolac taken by mouth every 6 hours for 5 days | Drug | Ketorolac group |
Primary outcome
Visual Analog Pain Score
Time frame: 5 days
Patient Reported Visual Analogue Score scored from 0-10 with lower scores equaling less pain.
2 secondary outcomes
Number of Study Pills Used
Time frame: Post-operative days 1 to 5
Use of Rescue Medication (Opioid)
Time frame: post operative day 1-5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sriharan Sivalingam, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxycodone and Ketorolac in people with Kidney Calculi and Ureteral Calculi, run by The Cleveland Clinic 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 4 inclusion and 10 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 23 Dec 2025. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 23 Dec 2025). 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?
Visual Analog Pain Score (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Dec 2025.