PainPhase 2NCT04112160
Prospective Randomized Controlled Trial for Pain Relief After Office Ureteral Stent Removal
A Phase 2 study testing Ketorolac and normal saline in people with Pain and Urinary Stone, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This is a prospective randomized double-blind controlled trial assessing the benefits of intramuscular ketorolac before or immediately after office ureteral stent removal. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Pain, Urinary Stone, Urinary Calculi
- What is being tested?
- Ketorolac and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2018to 30 Aug 2019
- Phase
- Phase 2
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients 18 to 79 who have undergone a cystoscopy with indwelling double-J ureteral stent placement at Clements University Hospital and are presenting to the office for cystoscopy and stent removal.
Who cannot join
- eGFR <50
- any active or history of peptic ulcer disease or GI bleeding
- Bleeding disorder, suspected of confirmed cerebrovascular bleeding, hemorrhagic diathesis, or incomplete hemostasis
- Concurrent use of Aspirin 325mg, wafarin, rivaroxaban, apixaban, clopidogrel, or heparin
- Allergic reaction to NSAIDs
- Concurrent use of other NSAIDs within 24 hours
- Pregnancy (ketorolac contraindicated in this population)
- Recent myocardial infarction (MI)
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective randomized double-blind controlled trial assessing the benefits of intramuscular ketorolac before or immediately after office ureteral stent removal.
Read the detailed description
Patients who are undergoing cystoscopy with ureteral stent removal at the University of Texas Southwestern Medical Center and have no contraindications to receiving ketorolac will be eligible. Patients will be randomized to receive either a 1 mL injection of ketorolac tromethamine or 1 mL injection of normal saline (0.9%) as the control arm. Ketorolac is a member of the pyrrolo-pyrrole group of non steroid anti inflammatory drugs. The mechanism of action of ketorolac, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition. The peak analgesic effect occurs within 2-3 hours. If no contraindications exist, ketorolac can be safely given to patients of any age in the 30 mg intramuscular formulation if given as a one time dose according to the package insert.
Normal saline contains 0.9% of Sodium chloride in each mL. Like ketorolac, it is a clear solution and given that there are no major side effects of normal saline it is a good control for our study. It is packaged in a single dose vial that contains 100 mL. It is preservative free and stored at room temperature (20-25°C). Local pain at the injection site may occur, temporarily.
The investigators will specifically look at pain scores before and after stent removal as well as narcotic medication use, telephone calls and/or emergency room visits for pain. Based on the rate of renal colic from our quality improvement project and prior work, the investigators calculated the maximum number of local subjects to be consented for this study to be n=116 (see biostatistics section). The study is expected to last 6 months.
- Conditions
- Pain, Urinary Stone, Urinary Calculi
- Being tested
- Ketorolac, normal saline
- Keywords
- stent removal, pain, kidney stones
- Medical subject headings
- Pain, Urinary Calculi, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
Also called Toradol
IM injection of either normal saline or Ketorolac
normal salineDrug
Also called Placebo
normal saline
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | normal saline 0.9% Receives: Drug: normal saline |
| Ketorolac | Active comparator | 30 mg of Ketorolac Receives: Drug: Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Unscheduled Return to Clinic or Emergency Room
Any unscheduled in-person clinical encounter secondary to renal colic following ureteral stent removal.
Measured: Seven days following ureteral stent removal.
Median Visual Analog Pain (VAS) Pain Scale Experienced by Participant 24 Hours Following Stent Removal
Perceived pain on a scale of 0-10 (0= no pain, 10= worst pain ever experienced) recorded by phone call 24 hours after stent removal.
Measured: Twenty-four hours following ureteral stent removal.
Number of Participants That Experienced an Injection Complication
Determine if there is any infection site pain or reaction. Determine any complications related to administration of the medication.
Measured: Within thirty days post injection.
Visual Analog Pain (VAS) Pain Scale 7 Days Following Stent Removal.
Perceived pain on a scale of 0-10 (0= no pain, 10= worst pain ever experienced) recorded by phone call 7 days after stent removal.
Measured: Seven days following ureteral stent removal.
Secondary outcomes (2)
Number of Patients That Required Opioid Medication Following Ureteral Stent Removal
Determine the use of opioid medications in morphine equivalents in the 24 hours following stent removal.
Measured: Twenty-four hours following stent removal.
Average Number of Days the Participant Missed Work
Determine amount of missed work or school due to renal colic following ureteral stent removal.
Measured: Seven days following stent removal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start28 Jun 2018
- Primary completion30 Jun 2019
- Study completion30 Aug 2019
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 PainStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret Pearle, University of Texas Southwestern Medical Center
- Investigators
- Margaret Pearle, MD.PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112160
- Sponsor's protocol ID
- STU 012018-080
- Status last verified
- Jan 2024
- First submitted
- 25 Sep 2019
- Last updated
- 10 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Johnson BA, Akhtar A, Crivelli J, Steinberg RL, Sasaki J, Street A, Antonelli JA, Pearle MS. Impact of an Enhanced Recovery After Surgery Protocol on Unplanned Patient Encounters in the Early Postoperative Period After Ureteroscopy. J Endourol. 2022 Mar;36(3):298-302. doi: 10.1089/end.2021.0435. Epub 2021 Oct 14.
PubMed 34569278
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial for Pain Relief After Office Ureteral Stent Removal
- ClinicalTrials.gov ID
- NCT04112160
- Acronym / sponsor ID
- STU 012018-080
- Conditions
- Pain, Urinary Stone, Urinary Calculi
- Keywords
- stent removal, pain, kidney stones
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 2 Oct 2019 (actual)
- Results
- Posted 22 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective randomized double-blind controlled trial assessing the benefits of intramuscular ketorolac before or immediately after office ureteral stent removal.
Detailed description
Patients who are undergoing cystoscopy with ureteral stent removal at the University of Texas Southwestern Medical Center and have no contraindications to receiving ketorolac will be eligible. Patients will be randomized to receive either a 1 mL injection of ketorolac tromethamine or 1 mL injection of normal saline (0.9%) as the control arm. Ketorolac is a member of the pyrrolo-pyrrole group of non steroid anti inflammatory drugs. The mechanism of action of ketorolac, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition. The peak analgesic effect occurs within 2-3 hours. If no contraindications exist, ketorolac can be safely given to patients of any age in the 30 mg intramuscular formulation if given as a one time dose according to the package insert.
Normal saline contains 0.9% of Sodium chloride in each mL. Like ketorolac, it is a clear solution and given that there are no major side effects of normal saline it is a good control for our study. It is packaged in a single dose vial that contains 100 mL. It is preservative free and stored at room temperature (20-25°C). Local pain at the injection site may occur, temporarily.
The investigators will specifically look at pain scores before and after stent removal as well as narcotic medication use, telephone calls and/or emergency room visits for pain. Based on the rate of renal colic from our quality improvement project and prior work, the investigators calculated the maximum number of local subjects to be consented for this study to be n=116 (see biostatistics section). The study is expected to last 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Drug: normal salinenormal saline 0.9% |
| Ketorolac | Active comparator | Drug: Ketorolac30 mg of Ketorolac |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients 18 to 79 who have undergone a cystoscopy with indwelling double-J ureteral stent placement at Clements University Hospital and are presenting to the office for cystoscopy and stent removal.
Key exclusion criteria (8 listed)
- eGFR <50
- any active or history of peptic ulcer disease or GI bleeding
- Bleeding disorder, suspected of confirmed cerebrovascular bleeding, hemorrhagic diathesis, or incomplete hemostasis
- Concurrent use of Aspirin 325mg, wafarin, rivaroxaban, apixaban, clopidogrel, or heparin
- Allergic reaction to NSAIDs
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 |
|---|---|---|
| KetorolacAlso: ToradolIM injection of either normal saline or Ketorolac | Drug | Ketorolac |
| normal salineAlso: Placebonormal saline | Drug | control |
Primary outcome
Number of Participants With Unscheduled Return to Clinic or Emergency Room
Time frame: Seven days following ureteral stent removal.
Any unscheduled in-person clinical encounter secondary to renal colic following ureteral stent removal.
Median Visual Analog Pain (VAS) Pain Scale Experienced by Participant 24 Hours Following Stent Removal
Time frame: Twenty-four hours following ureteral stent removal.
Perceived pain on a scale of 0-10 (0= no pain, 10= worst pain ever experienced) recorded by phone call 24 hours after stent removal.
Number of Participants That Experienced an Injection Complication
Time frame: Within thirty days post injection.
Determine if there is any infection site pain or reaction. Determine any complications related to administration of the medication.
Visual Analog Pain (VAS) Pain Scale 7 Days Following Stent Removal.
Time frame: Seven days following ureteral stent removal.
Perceived pain on a scale of 0-10 (0= no pain, 10= worst pain ever experienced) recorded by phone call 7 days after stent removal.
2 secondary outcomes
Number of Patients That Required Opioid Medication Following Ureteral Stent Removal
Time frame: Twenty-four hours following stent removal.
Average Number of Days the Participant Missed Work
Time frame: Seven days following stent removal.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34569278Johnson BA, Akhtar A, Crivelli J, Steinberg RL, Sasaki J, Street A, Antonelli JA, Pearle MS. Impact of an Enhanced Recovery After Surgery Protocol on Unplanned Patient Encounters in the Early Postoperative Period After Ureteroscopy. J Endourol. 2022 Mar;36(3):298-302. doi: 10.1089/end.2021.0435. Epub 2021 Oct 14.
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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.
Margaret Pearle, MD.PhD principal investigator
University of Texas Southwestern 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 2 study testing Ketorolac and normal saline in people with Pain and Urinary Stone, run by University of Texas Southwestern 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 1 inclusion and 8 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 10 Jan 2024. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 22 Jul 2020). 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?
Number of Participants With Unscheduled Return to Clinic or Emergency Room (time frame: Seven days following ureteral stent removal.). The study lists 4 primary outcomes in all. 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 NCT04112160, 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 10 Jan 2024.