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NCT06158620 · ClinicalTrials.gov registry record · Phase 1
Intra-nasal Ketorolac for Acute Ureteral Stent-associated Pain Following Ureteroscopy for Stone Disease
A Phase 1 study of Postoperative Pain and Urolithiasis, sponsored by University of Texas Southwestern Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT06158620: Recruiting Phase 1 study of Postoperative Pain and Urolithiasis, sponsored by University of Texas Southwestern Medical Center.
NCT06158620 is a Phase 1 study of Postoperative Pain and Urolithiasis that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 80 participants, below the 231-participant average among 120 other Postoperative Pain trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06158620, a Phase 1 study of Postoperative Pain and Urolithiasis, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study 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 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG intra-nasal ketorolac
- DRUG oral diclofenac
Study Locations (1)
Texas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2025-03-01 |
| Est. Completion | 2026-12-01 |
| Phase | Phase 1 |
What NCT06158620 shows while recruiting
NCT06158620 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 231-participant average among 120 other Postoperative Pain trials with a reported enrollment target (65% lower).
The record links to 4 conditions, with Postoperative Pain appearing as the primary indexed condition, and to 2 interventions - of which intra-nasal ketorolac is the first listed.
NCT06158620 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06158620 about?
NCT06158620 is a clinical study titled "Intra-nasal Ketorolac 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 tr...
What is the current status of trial NCT06158620?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2025-03-01. Estimated completion is 2026-12-01.
What conditions does trial NCT06158620 study?
This clinical trial studies the following conditions: Postoperative Pain, Urolithiasis, Ureter Calculi, Stent Complication.
What interventions are being tested in trial NCT06158620?
The interventions under investigation include: intra-nasal ketorolac (DRUG), oral diclofenac (DRUG).
Who is sponsoring clinical trial NCT06158620?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06158620 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06158620's enrollment target sits among peer trials
80 69th of 120 higher than 47 of 120 other Postoperative Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postoperative Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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