Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
ID06158620

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

Led by University of Texas Southwestern Medical Center · Updated on 2026-05-27

80

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

Sponsors

U

University of Texas Southwestern Medical Center

Lead Sponsor

A

assertio Therapeutics, Inc

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are exploring ways to improve quality of life and health care delivery for patients who have ureteral stents after surgery to remove kidney stones. The study focuses on comparing two pain relief options: intra-nasal ketorolac and oral diclofenac, both non-steroidal anti-inflammatory drugs (NSAIDs). This research includes a Phase I pilot and a Phase II randomized trial to understand pain control and reduce unplanned medical visits related to stent discomfort. The study begins with a Phase I single-arm pilot involving 20 patients using intra-nasal ketorolac to assess feasibility and patient experiences. In Phase II, 60 patients will be randomly assigned to receive either intra-nasal ketorolac or oral diclofenac in addition to standard care after ureteroscopy and stent placement. Both treatments are given as needed to manage post-operative pain and discomfort caused by the ureteral stent. Participants will complete pain assessments before surgery and on the day of stent removal, using multiple pain measurement tools. Researchers will track changes in pain scores and the number of unplanned clinical visits due to stent-related symptoms. The study will also monitor the practicality and patient feedback on intra-nasal ketorolac use, with follow-up focused on outcomes between postoperative day 5 and 10, lasting until the stent is removed.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years old or older
  • English-speaking
  • Candidate for unilateral ureteroscopy to treat urolithiasis
  • Surgical plan includes placement of a ureteral stent
Not Eligible

You will not qualify if you...

  • Pregnant or nursing women
  • Prisoners
  • Cognitively impaired individuals
  • Solitary kidney
  • Stone in transplant kidney
  • Anatomic abnormalities such as ureteral stricture, infundibular stenosis, uretero-pelvic junction obstruction, horseshoe kidney, or duplicated system
  • History of ureteral reconstruction
  • History of nephrocalcinosis, medullary sponge kidney, or cystinuria
  • Immobility or relative immobility
  • Planned staged ureteroscopy
  • History of ureteral stent complication or poor tolerance
  • Urinary tract infection or sepsis
  • Current use of anticoagulation medications (81 mg Aspirin allowed)
  • Contraindication to NSAIDs including acute renal failure, chronic kidney disease, bleeding disorders, allergic reaction to NSAIDs, ulcer disease, or auto-immune disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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2
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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - From day of ureteroscopy through post-operative day 5 to 10 until ureter stent removal

Participants receive either intra-nasal ketorolac or oral diclofenac to manage post-operative pain and ureteral stent discomfort following ureteroscopy.

Baseline visit before surgery and 1 visit for stent removal

Trial Site Locations

Total: 1 location

1

UT Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

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Research Team

B

Brett Johnson, MD

I

Isaac Palma-Zamora, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Direct and indirect costs of nephrolithiasis in an employed population: opportunity for disease management?

Christopher S Saigal, Geoffrey Joyce, Anga R Timilsina...

https://pubmed.ncbi.nlm.nih.gov/16164658