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Intra-nasal Ketorolac for Ureteral Stent Pain After Kidney Stone Surgery

This study is looking at ways to manage pain after kidney stone surgery (ureteroscopy) when a ureteral stent is placed. Researchers are comparing intra-nasal ketorolac, a pain medication given through the nose, with oral diclofenac, a similar medication taken by mouth. The goal is to see if intra-nasal ketorolac can better reduce pain and improve your quality of life. You might be able to join if you are at least 18 years old, speak English, and are having ureteroscopy for kidney stones with a stent placement. Success will be measured by changes in your pain scores using different questionnaires. The study plans to enroll 80 participants, but its current status is unclear.

Study design
This is an interventional study comparing two pain medications, intra-nasal ketorolac and oral diclofenac, in about 80 participants.
What's involved
You would complete pain questionnaires before surgery and again when your ureteral stent is removed (between 5 and 10 days after surgery).
Compensation
Not stated in the trial record.
Follow-up
Your pain will be measured at baseline (before surgery) and again when your ureteral stent is removed (between 5 and 10 days after surgery).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06158620

Intra-nasal Ketorolac for Acute Ureteral Stent-associated Pain Following Ureteroscopy for Stone Disease

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Texas Southwestern Medical Center
~80 participants
Updated 2026-05-27 on ClinicalTrials.gov
What's tested:intra-nasal ketorolacoral diclofenac

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in pain scores as measured by USSQ Pain Survey
Measured over Baseline (before surgery in the pre-operative setting -Day 0), the day of ureter stent removal (Post-operative day 5 through 10)
+2 more outcomes measured

Conditions

Post Operative Pain
Urolithiasis
Ureter Calculi
Stent Complication

Explore related trials

Post-Operative PainUrolithiasis

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Brett Johnson, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

Who to contact

Brett Johnson, MD
[email protected]
214/645-8765
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

≥18 years old
English-speaking
Candidate for unilateral ureteroscopy for treatment of urolithiasis
Surgical plan includes placement of a ureteral stent

Exclusion

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
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)

What this trial measures

  • Change in pain scores as measured by USSQ Pain SurveyBaseline (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 questionnaireBaseline (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 QuestionnaireBaseline (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.