Post Operative PainPhase 1/2NCT06158620
Intra-nasal Ketorolac for Acute Ureteral Stent-associated Pain Following Ureteroscopy for Stone Disease
A Phase 1/2 study testing intra-nasal ketorolac and oral diclofenac in people with Post Operative Pain and Urolithiasis, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Objective: To improve quality-of-life and health care delivery to patients receiving ureteral stents. Specific Aims: Evaluate the feasibility, practicality, and qualitative outcomes of utilizing intra-nasal ketorolac in patients with indwelling ureteral stents (Phase I), followed by a randomized trial comparing two… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Pain, Urolithiasis, Ureter Calculi
- What is being tested?
- intra-nasal ketorolac and oral diclofenac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to 1 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old
- English-speaking
- Candidate for unilateral ureteroscopy for treatment of urolithiasis
- Surgical plan includes placement of a ureteral stent
Who cannot join
- Pregnant/nursing, prisoners, cognitively impaired
- Solitary kidney
- Stone in transplant kidney
- Anatomic abnormalities (i.e., ureteral stricture, infundibular stenosis, uretero-pelvic junction obstruction, horseshoe kidney, duplicated system)
- History of ureteral reconstruction
- History of nephrocalcinosis, medullary sponge kidney, cystinuria
Show all 12Show fewer
- Immobility or relative immobility
- Planned staged ureteroscopy
- History of ureteral stent complication or poor tolerance or a ureteral stent
- Urinary tract infection or sepsis
- Current anticoagulation use (81 mg Aspirin permissible)
- NSAID contraindication (acute renal failure or chronic kidney disease, bleeding disorders, allergic reaction to NSAIDs, ulcer disease, auto-immune disease)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Brett Johnson, MD
About this study
Official title: Intra-nasal Ketorolac Versus Oral Diclofenac for Acute Ureteral Stent-associated Pain Following Ureteroscopy for Stone Disease
Objective: To improve quality-of-life and health care delivery to patients receiving ureteral stents.
Specific Aims: Evaluate the feasibility, practicality, and qualitative outcomes of utilizing intra-nasal ketorolac in patients with indwelling ureteral stents (Phase I), followed by a randomized trial comparing two non-steroidal anti-inflammatory drugs, intra-nasal Ketorolac versus oral Diclofenac.
Read more
Hypotheses: Due to its favorable pharmacokinetics in relieving acute pain, investigators expect improved pain scores and a lower rate of unplanned clinical encounters in patients receiving intra-nasal ketorolac compared to those taking oral diclofenac following ureteroscopic surgery for urolithiasis.
Study Rationale: Following ureteroscopic management of urolithiasis, patient with indwelling ureter stents have higher levels of discomfort compared to those without a ureter stent. Prior studies showed that intramuscular Ketorolac at time of ureter stent removal decreased the incidence of unplanned clinical encounters. Furthermore, onset of analgesic effect by intra-nasal ketorolac is faster than its oral form, and similar its intramuscular and intravenous counterparts.
Read the detailed description
Urinary stone disease (USD) leads to pain, diminished quality of life, missed work and school, chronic kidney disease, and renal failure.1-5 The prevalence of kidney stone disease in adults has risen to almost 9% as of 2010 in the United States (US). The 5-year recurrence rate without treatment is 53%.6,7 Increasing utilization of a ureteroscopic approach to treat urolithiasis has led to an increased proportion of stone patients undergoing ureteral stent placement.
In the US, approximately 90% of patients receive a ureteral stent following ureteroscopy. Some patients that undergo ureteral stent placement experience significant and debilitating symptoms of urinary urgency, frequency, suprapubic and flank pain, and incontinence. Treatment of these symptoms has historically relied heavily on opioid pain medications. However, recent emphasis on risk associated with opioid medications has reduced their use, and paved the way for alternative approaches. As such, non-steroidal anti-inflammatory drugs (NSAIDs) have become an integral part of multimodal techniques at mitigating post operative pain and associated ureter stent discomfort.
Ketorolac, an NSAID, can be used in the management of acute pain related to ureteral obstruction, renal colic, and indwelling ureter stent. There are four available formulations of ketorolac: oral, intra-muscular (IM), intra-nasal (IN), and intravenous (IV). Non-oral formulations are known to have faster onset of action and an earlier peak analgesic effect.8 As opposed to injectable (IM or IV) ketorolac that needs to be administered by a clinical provider, IN ketorolac may conveniently be self-administered.9 Furthermore, the favorable pharmacokinetics of IN ketorolac allow for its significant efficacy in providing timely pain relief without the need of opioid medications. However, one of the significant barriers of intra-nasal ketorolac is the cost. An intra-nasal course can cause upwards of $1500 compared to $20 of oral ketorolac.
Ketorolac prevents unplanned renal colic-related clinical encounters post stent removal.10 Study team recently published the study team's results from a randomized trial comparing intramuscular injection of ketorolac to placebo at the time ureteral stent removal reduced the incidence of unplanned clinic returns or emergency room visits. While this trial was aimed at the small number of patients that develop severe ureteral colic following stent removal, investigators feel ketorolac's strong anti-inflammatory properties can be leveraged to mitigate acute indwelling ureteral stent symptoms.
While it is not feasible to treat every stent patient empirically with IN ketorolac, there may be an identifiable subset of patients that may benefit from this formulation. Its favorable pharmacokinetics allow for its significant efficacy in providing timely pain relief without the need of opioid medications. This makes IN ketorolac an intriguing option that may decrease unplanned clinical encounters related to indwelling ureter stent discomfort. Especially when the cost of a post-operative emergency room visits which can include laboratory testing, computed tomography, IV medication and possible admission can dwarf the cost of IN ketorolac.
Furthermore, a recent qualitative analysis published by Harper et al in the in the STudy to Enhance uNderstanding of sTent-associated Symptoms (STENTS) study reveal a highly variable patient experience with stents.11 For some, the negative experience of the stent can be life altering. Therefore, there is a critical need to improve the pain and quality of life of those requiring ureteral stenting. Ideally, this can be done in a directed way to offer more relief to those patients most at risk for severe symptoms.
- Conditions
- Post Operative Pain, Urolithiasis, Ureter Calculi, Stent Complication
- Being tested
- intra-nasal ketorolac, oral diclofenac
- Medical subject headings
- Pain, Postoperative, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-nasal ketorolacDrug
Also called Sprix
Experimental group receiving intra-nasal ketorolac for management of post-operative pain following ureteroscopy for kidney stone, and associated ureter stent discomfort.
oral diclofenacDrug
Control group to receive oral diclofenac, which is a comparable medication to intra-nasal ketorolac.
| Study group | Role | What they receive |
|---|---|---|
| Sprix | Experimental | Phase I will consist of a single-arm open label pilot study. Prior to the initiation of a large-scale randomized trial, we propose a single-arm open label pilot study to evaluate the feasibility, practicality, and qualitative outcomes of utilizing intra-nasal ketorolac in patients with indwelling ureteral stents. We seek to enroll 20 patients for the initial pilot.
Phase II will consist of a randomized trial comparing intranasal ketorolac to Diclofenac, a commonly used oral NSAID. , Diclofenac potassium. Following ureteroscopy and stent placement, patients will receive standard of care medications to mitigate post operative pain and stent discomfort, and will be randomized to receive either as needed intra-nasal ketorolac or oral diclofenac. We seek to enroll and randomize 60 patients in a 1:1 fashion. Analysis will be intention to treat. Receives: Drug: intra-nasal ketorolac |
| Diclofenac | Active comparator | Phase II will consist of a randomized trial comparing intranasal ketorolac to Diclofenac, a commonly used oral NSAID. , Diclofenac potassium. Following ureteroscopy and stent placement, patients will receive standard of care medications to mitigate post operative pain and stent discomfort, and will be randomized to receive either as needed intra-nasal ketorolac or oral diclofenac. We seek to enroll and randomize 60 patients in a 1:1 fashion. Analysis will be intention to treat. Receives: Drug: oral diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain scores as measured by USSQ Pain Survey
Associated pain burden will be measured using standardized Ureteral Stent Symptom Questionnaire (USSQ) Pain Survey. Possible scores range from 0-10, where lower scores indicate better outcome.
Measured: Baseline (before surgery in the pre-operative setting -Day 0), the day of ureter stent removal (Post-operative day 5 through 10)
Change in pain scores as measured by PROMIS questionnaire
Associated pain burden will be measured using standardized Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity and Interference questionnaire. Possible scores range from 0-10, where lower scores indicate better outcome.
Measured: Baseline (before surgery in the pre-operative setting -Day 0), the day of ureter stent removal (Post-operative day 5 through 10)
Change in pain scores as measured by Likert Scale Questionnaire
Associated pain burden will be measured using standardized Likert Scale Questionnaire. Possible scores range from 0-10, where lower scores indicate better outcome.
For those patients in the SPIRIX arm, they will be asked to complete the Likert Scale Questionnaire approximately 30 minutes after taking each SPIRIX dose.
Measured: Baseline (before surgery in the pre-operative setting -Day 0), the day of ureter stent removal (Post-operative day 5 through 10)
Secondary outcomes (1)
Number of unplanned clinical encounters
number of clinical encounters (i.e. telephone calls, MyChart messages, emergency room visits, hospital readmissions) related to ureter stent discomfort will be counted.
Measured: Post-operative setting -the day of ureter stent removal (Post-operative day 5 through 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start1 Mar 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Post Operative 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase I will consist of a single-arm open label pilot study. Prior to the initiation of a large-scale randomized trial, we propose a single-arm open label pilot study to evaluate the feasibility, practicality, and qualitative outcomes of utilizing intra-nasal ketorolac in patients with indwelling ureteral stents. We seek to enroll 20 patients for the initial pilot. Phase II will consist of a randomized trial comparing intranasal ketorolac to Diclofenac, a commonly used oral NSAID. , Diclofenac potassium. Following ureteroscopy and stent placement, patients will receive standard of care medications to mitigate post operative pain and stent discomfort, and will be randomized to receive either as needed intra-nasal ketorolac or oral diclofenac. We seek to enroll and randomize 60 patients in a 1:1 fashion. Analysis will be intention to treat.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- assertio Therapeutics, Inc
- Responsible party
- Principal investigator, Brett Johnson, University of Texas Southwestern Medical Center
- Investigators
- Brett Johnson, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158620
- Sponsor's protocol ID
- STU-2023-0775
- Status last verified
- May 2026
- First submitted
- 26 Nov 2023
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pearle MS. Medical therapy for urinary stone passage. Lancet. 2006 Sep 30;368(9542):1138-9. doi: 10.1016/S0140-6736(06)69452-X. No abstract available.
PubMed 17011928Bensalah K, Tuncel A, Gupta A, Raman JD, Pearle MS, Lotan Y. Determinants of quality of life for patients with kidney stones. J Urol. 2008 Jun;179(6):2238-43; discussion 2243. doi: 10.1016/j.juro.2008.01.116. Epub 2008 Apr 18.
PubMed 18423704Saigal CS, Joyce G, Timilsina AR; Urologic Diseases in America Project. Direct and indirect costs of nephrolithiasis in an employed population: opportunity for disease management? Kidney Int. 2005 Oct;68(4):1808-14. doi: 10.1111/j.1523-1755.2005.00599.x.
PubMed 16164658Shoag J, Halpern J, Goldfarb DS, Eisner BH. Risk of chronic and end stage kidney disease in patients with nephrolithiasis. J Urol. 2014 Nov;192(5):1440-5. doi: 10.1016/j.juro.2014.05.117. Epub 2014 Jun 11.
PubMed 24929140Alexander RT, Hemmelgarn BR, Wiebe N, Bello A, Morgan C, Samuel S, Klarenbach SW, Curhan GC, Tonelli M; Alberta Kidney Disease Network. Kidney stones and kidney function loss: a cohort study. BMJ. 2012 Aug 29;345:e5287. doi: 10.1136/bmj.e5287.
PubMed 22936784Ljunghall S, Danielson BG. A prospective study of renal stone recurrences. Br J Urol. 1984 Apr;56(2):122-4. doi: 10.1111/j.1464-410x.1984.tb05346.x.
PubMed 6498430Uribarri J, Oh MS, Carroll HJ. The first kidney stone. Ann Intern Med. 1989 Dec 15;111(12):1006-9. doi: 10.7326/0003-4819-111-12-1006.
PubMed 2688503Vadivelu N, Gowda AM, Urman RD, Jolly S, Kodumudi V, Maria M, Taylor R Jr, Pergolizzi JV Jr. Ketorolac tromethamine - routes and clinical implications. Pain Pract. 2015 Feb;15(2):175-93. doi: 10.1111/papr.12198. Epub 2014 Apr 16.
PubMed 24738596Singla N, Singla S, Minkowitz HS, Moodie J, Brown C. Intranasal ketorolac for acute postoperative pain. Curr Med Res Opin. 2010 Aug;26(8):1915-23. doi: 10.1185/03007995.2010.495564.
PubMed 20557145Johnson BA, Sorokin I, Antonelli J, Pearle M. Efficacy of Intramuscular Ketorolac for Preventing Renal Colic Post Stent Removal: Randomized Controlled Trial. J Urol. 2022 Sep;208(3):650-657. doi: 10.1097/JU.0000000000002750. Epub 2022 Jun 2.
PubMed 35653577Harper JD, Desai AC, Antonelli JA, Tasian GE, Ziemba JB, Al-Khalidi HR, Lai HH, Maalouf NM, Reese PP, Wessells HB, Kirkali Z, Scales CD Jr; NIDDK Urinary Stone Disease Research Network (USDRN). Quality of life impact and recovery after ureteroscopy and stent insertion: insights from daily surveys in STENTS. BMC Urol. 2022 Apr 6;22(1):53. doi: 10.1186/s12894-022-01004-9.
PubMed 35387623Allam CL, Aden JK, Reed AM. The Role of Routine Ureteral Stenting Following Uncomplicated Ureteroscopic Treatment for Upper Ureteral and Renal Stones: A Randomized Control Trial. J Endourol. 2023 Mar;37(3):257-263. doi: 10.1089/end.2022.0386. Epub 2023 Jan 9.
PubMed 36401514
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-nasal Ketorolac Versus Oral Diclofenac for Acute Ureteral Stent-associated Pain Following Ureteroscopy for Stone Disease
- ClinicalTrials.gov ID
- NCT06158620
- Acronym / sponsor ID
- STU-2023-0775
- Conditions
- Post Operative Pain, Urolithiasis, Ureter Calculi, Stent Complication
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- assertio Therapeutics, Inc
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: To improve quality-of-life and health care delivery to patients receiving ureteral stents.
Specific Aims: Evaluate the feasibility, practicality, and qualitative outcomes of utilizing intra-nasal ketorolac in patients with indwelling ureteral stents (Phase I), followed by a randomized trial comparing two non-steroidal anti-inflammatory drugs, intra-nasal Ketorolac versus oral Diclofenac.
Hypotheses: Due to its favorable pharmacokinetics in relieving acute pain, investigators expect improved pain scores and a lower rate of unplanned clinical encounters in patients receiving intra-nasal ketorolac compared to those taking oral diclofenac following ureteroscopic surgery for urolithiasis.
Study Rationale: Following ureteroscopic management of urolithiasis, patient with indwelling ureter stents have higher levels of discomfort compared to those without a ureter stent. Prior studies showed that intramuscular Ketorolac at time of ureter stent removal decreased the incidence of unplanned clinical encounters. Furthermore, onset of analgesic effect by intra-nasal ketorolac is faster than its oral form, and similar its intramuscular and intravenous counterparts.
Detailed description
Urinary stone disease (USD) leads to pain, diminished quality of life, missed work and school, chronic kidney disease, and renal failure.1-5 The prevalence of kidney stone disease in adults has risen to almost 9% as of 2010 in the United States (US). The 5-year recurrence rate without treatment is 53%.6,7 Increasing utilization of a ureteroscopic approach to treat urolithiasis has led to an increased proportion of stone patients undergoing ureteral stent placement.
In the US, approximately 90% of patients receive a ureteral stent following ureteroscopy. Some patients that undergo ureteral stent placement experience significant and debilitating symptoms of urinary urgency, frequency, suprapubic and flank pain, and incontinence. Treatment of these symptoms has historically relied heavily on opioid pain medications. However, recent emphasis on risk associated with opioid medications has reduced their use, and paved the way for alternative approaches. As such, non-steroidal anti-inflammatory drugs (NSAIDs) have become an integral part of multimodal techniques at mitigating post operative pain and associated ureter stent discomfort.
Ketorolac, an NSAID, can be used in the management of acute pain related to ureteral obstruction, renal colic, and indwelling ureter stent. There are four available formulations of ketorolac: oral, intra-muscular (IM), intra-nasal (IN), and intravenous (IV). Non-oral formulations are known to have faster onset of action and an earlier peak analgesic effect.8 As opposed to injectable (IM or IV) ketorolac that needs to be administered by a clinical provider, IN ketorolac may conveniently be self-administered.9 Furthermore, the favorable pharmacokinetics of IN ketorolac allow for its significant efficacy in providing timely pain relief without the need of opioid medications. However, one of the significant barriers of intra-nasal ketorolac is the cost. An intra-nasal course can cause upwards of $1500 compared to $20 of oral ketorolac.
Ketorolac prevents unplanned renal colic-related clinical encounters post stent removal.10 Study team recently published the study team's results from a randomized trial comparing intramuscular injection of ketorolac to placebo at the time ureteral stent removal reduced the incidence of unplanned clinic returns or emergency room visits. While this trial was aimed at the small number of patients that develop severe ureteral colic following stent removal, investigators feel ketorolac's strong anti-inflammatory properties can be leveraged to mitigate acute indwelling ureteral stent symptoms.
While it is not feasible to treat every stent patient empirically with IN ketorolac, there may be an identifiable subset of patients that may benefit from this formulation. Its favorable pharmacokinetics allow for its significant efficacy in providing timely pain relief without the need of opioid medications. This makes IN ketorolac an intriguing option that may decrease unplanned clinical encounters related to indwelling ureter stent discomfort. Especially when the cost of a post-operative emergency room visits which can include laboratory testing, computed tomography, IV medication and possible admission can dwarf the cost of IN ketorolac.
Furthermore, a recent qualitative analysis published by Harper et al in the in the STudy to Enhance uNderstanding of sTent-associated Symptoms (STENTS) study reveal a highly variable patient experience with stents.11 For some, the negative experience of the stent can be life altering. Therefore, there is a critical need to improve the pain and quality of life of those requiring ureteral stenting. Ideally, this can be done in a directed way to offer more relief to those patients most at risk for severe symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase I will consist of a single-arm open label pilot study. Prior to the initiation of a large-scale randomized trial, we propose a single-arm open label pilot study to evaluate the feasibility, practicality, and qualitative outcomes of utilizing intra-nasal ketorolac in patients with indwelling ureteral stents. We seek to enroll 20 patients for the initial pilot. Phase II will consist of a randomized trial comparing intranasal ketorolac to Diclofenac, a commonly used oral NSAID. , Diclofenac potassium. Following ureteroscopy and stent placement, patients will receive standard of care medications to mitigate post operative pain and stent discomfort, and will be randomized to receive either as needed intra-nasal ketorolac or oral diclofenac. We seek to enroll and randomize 60 patients in a 1:1 fashion. Analysis will be intention to treat.
| Arm | Type | Receives |
|---|---|---|
| Sprix | Experimental | Drug: intra-nasal ketorolacPhase I will consist of a single-arm open label pilot study. Prior to the initiation of a large-scale randomized trial, we propose a single-arm open label pilot study to evaluate the feasibility, practicality, and qualitative outcomes of utilizing intra-nasal ketorolac in patients with indwelling ureteral stents. We seek to enroll 20 patients for the initial pilot. Phase II will consist of a randomized trial comparing intranasal ketorolac to Diclofenac, a commonly used oral NSAID. , Diclofenac potassium. Following ureteroscopy and stent placement, patients will receive standard of care medications to mitigate post operative pain and stent discomfort, and will be randomized to receive either as needed intra-nasal ketorolac or oral diclofenac. We seek to enroll and randomize 60 patients in a 1:1 fashion. Analysis will be intention to treat. |
| Diclofenac | Active comparator | Drug: oral diclofenacPhase II will consist of a randomized trial comparing intranasal ketorolac to Diclofenac, a commonly used oral NSAID. , Diclofenac potassium. Following ureteroscopy and stent placement, patients will receive standard of care medications to mitigate post operative pain and stent discomfort, and will be randomized to receive either as needed intra-nasal ketorolac or oral diclofenac. We seek to enroll and randomize 60 patients in a 1:1 fashion. Analysis will be intention to treat. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years old
- English-speaking
- Candidate for unilateral ureteroscopy for treatment of urolithiasis
- Surgical plan includes placement of a ureteral stent
Key exclusion criteria (12 listed)
- Pregnant/nursing, prisoners, cognitively impaired
- Solitary kidney
- Stone in transplant kidney
- Anatomic abnormalities (i.e., ureteral stricture, infundibular stenosis, uretero-pelvic junction obstruction, horseshoe kidney, duplicated system)
- History of ureteral reconstruction
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 |
|---|---|---|
| intra-nasal ketorolacAlso: SprixExperimental group receiving intra-nasal ketorolac for management of post-operative pain following ureteroscopy for kidney stone, and associated ureter stent discomfort. | Drug | Sprix |
| oral diclofenacControl group to receive oral diclofenac, which is a comparable medication to intra-nasal ketorolac. | Drug | Diclofenac |
Primary outcome
Change in pain scores as measured by USSQ Pain Survey
Time frame: Baseline (before surgery in the pre-operative setting -Day 0), the day of ureter stent removal (Post-operative day 5 through 10)
Associated pain burden will be measured using standardized Ureteral Stent Symptom Questionnaire (USSQ) Pain Survey. Possible scores range from 0-10, where lower scores indicate better outcome.
Change in pain scores as measured by PROMIS questionnaire
Time frame: Baseline (before surgery in the pre-operative setting -Day 0), the day of ureter stent removal (Post-operative day 5 through 10)
Associated pain burden will be measured using standardized Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity and Interference questionnaire. Possible scores range from 0-10, where lower scores indicate better outcome.
Change in pain scores as measured by Likert Scale Questionnaire
Time frame: Baseline (before surgery in the pre-operative setting -Day 0), the day of ureter stent removal (Post-operative day 5 through 10)
Associated pain burden will be measured using standardized Likert Scale Questionnaire. Possible scores range from 0-10, where lower scores indicate better outcome. For those patients in the SPIRIX arm, they will be asked to complete the Likert Scale Questionnaire approximately 30 minutes after taking each SPIRIX dose.
1 secondary outcome
Number of unplanned clinical encounters
Time frame: Post-operative setting -the day of ureter stent removal (Post-operative day 5 through 10)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Background: PubMed 17011928Pearle MS. Medical therapy for urinary stone passage. Lancet. 2006 Sep 30;368(9542):1138-9. doi: 10.1016/S0140-6736(06)69452-X. No abstract available.
- Background: PubMed 18423704Bensalah K, Tuncel A, Gupta A, Raman JD, Pearle MS, Lotan Y. Determinants of quality of life for patients with kidney stones. J Urol. 2008 Jun;179(6):2238-43; discussion 2243. doi: 10.1016/j.juro.2008.01.116. Epub 2008 Apr 18.
- Background: PubMed 16164658Saigal CS, Joyce G, Timilsina AR; Urologic Diseases in America Project. Direct and indirect costs of nephrolithiasis in an employed population: opportunity for disease management? Kidney Int. 2005 Oct;68(4):1808-14. doi: 10.1111/j.1523-1755.2005.00599.x.
- Background: PubMed 24929140Shoag J, Halpern J, Goldfarb DS, Eisner BH. Risk of chronic and end stage kidney disease in patients with nephrolithiasis. J Urol. 2014 Nov;192(5):1440-5. doi: 10.1016/j.juro.2014.05.117. Epub 2014 Jun 11.
- Background: PubMed 22936784Alexander RT, Hemmelgarn BR, Wiebe N, Bello A, Morgan C, Samuel S, Klarenbach SW, Curhan GC, Tonelli M; Alberta Kidney Disease Network. Kidney stones and kidney function loss: a cohort study. BMJ. 2012 Aug 29;345:e5287. doi: 10.1136/bmj.e5287.
- Background: PubMed 6498430Ljunghall S, Danielson BG. A prospective study of renal stone recurrences. Br J Urol. 1984 Apr;56(2):122-4. doi: 10.1111/j.1464-410x.1984.tb05346.x.
- Background: PubMed 2688503Uribarri J, Oh MS, Carroll HJ. The first kidney stone. Ann Intern Med. 1989 Dec 15;111(12):1006-9. doi: 10.7326/0003-4819-111-12-1006.
- Background: PubMed 24738596Vadivelu N, Gowda AM, Urman RD, Jolly S, Kodumudi V, Maria M, Taylor R Jr, Pergolizzi JV Jr. Ketorolac tromethamine - routes and clinical implications. Pain Pract. 2015 Feb;15(2):175-93. doi: 10.1111/papr.12198. Epub 2014 Apr 16.
- Background: PubMed 20557145Singla N, Singla S, Minkowitz HS, Moodie J, Brown C. Intranasal ketorolac for acute postoperative pain. Curr Med Res Opin. 2010 Aug;26(8):1915-23. doi: 10.1185/03007995.2010.495564.
- Background: PubMed 35653577Johnson BA, Sorokin I, Antonelli J, Pearle M. Efficacy of Intramuscular Ketorolac for Preventing Renal Colic Post Stent Removal: Randomized Controlled Trial. J Urol. 2022 Sep;208(3):650-657. doi: 10.1097/JU.0000000000002750. Epub 2022 Jun 2.
- Background: PubMed 35387623Harper JD, Desai AC, Antonelli JA, Tasian GE, Ziemba JB, Al-Khalidi HR, Lai HH, Maalouf NM, Reese PP, Wessells HB, Kirkali Z, Scales CD Jr; NIDDK Urinary Stone Disease Research Network (USDRN). Quality of life impact and recovery after ureteroscopy and stent insertion: insights from daily surveys in STENTS. BMC Urol. 2022 Apr 6;22(1):53. doi: 10.1186/s12894-022-01004-9.
- Background: PubMed 36401514Allam CL, Aden JK, Reed AM. The Role of Routine Ureteral Stenting Following Uncomplicated Ureteroscopic Treatment for Upper Ureteral and Renal Stones: A Randomized Control Trial. J Endourol. 2023 Mar;37(3):257-263. doi: 10.1089/end.2022.0386. Epub 2023 Jan 9.
- 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.
Brett Johnson, MD 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 1/2 study testing intra-nasal ketorolac and oral diclofenac in people with Post Operative Pain and Urolithiasis, 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 4 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 27 May 2026. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brett Johnson, MD (214/645-8765, brett.johnson@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain scores as measured by USSQ Pain Survey (time frame: Baseline (before surgery in the pre-operative setting -Day 0), the day of ureter stent removal (Post-operative day 5 through 10)). The study lists 3 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 NCT06158620, which also lists 12 linked publications.
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 27 May 2026.