RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-01
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06158620

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥18 years old
  2. * English-speaking
  3. * Candidate for unilateral ureteroscopy for treatment of urolithiasis
  4. * Surgical plan includes placement of a ureteral stent
  1. * Pregnant/nursing, prisoners, cognitively impaired
  2. * Solitary kidney
  3. * Stone in transplant kidney
  4. * Anatomic abnormalities (i.e., ureteral stricture, infundibular stenosis, uretero-pelvic junction obstruction, horseshoe kidney, duplicated system)
  5. * History of ureteral reconstruction
  6. * History of nephrocalcinosis, medullary sponge kidney, cystinuria
  7. * Immobility or relative immobility
  8. * Planned staged ureteroscopy
  9. * History of ureteral stent complication or poor tolerance or a ureteral stent
  10. * Urinary tract infection or sepsis
  11. * Current anticoagulation use (81 mg Aspirin permissible)
  12. * NSAID contraindication (acute renal failure or chronic kidney disease, bleeding disorders, allergic reaction to NSAIDs, ulcer disease, auto-immune disease)

Contacts and Locations

Study Contact

Brett Johnson, MD
CONTACT
214/645-8765
brett.johnson@utsouthwestern.edu
Isaac Palma-Zamora, MD
CONTACT
214/645-8765
isaac.palma-zamora@utsouthwestern.edu

Principal Investigator

Brett Johnson, MD
PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center

Study Locations (Sites)

UT Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Brett Johnson, MD, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-01
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2025-03-01
Study Completion Date2025-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Post Operative Pain
  • Urolithiasis
  • Ureter Calculi
  • Stent Complication