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New treatment option for Post Operative Pain
Official title Intra-nasal Ketorolac for Acute Ureteral Stent-associated Pain Following Ureteroscopy for Stone Disease
ClinicalTrials.gov ID: NCT06158620
What this study is testing
What is intra-nasal ketorolac?
intra-nasal ketorolac is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for post operative pain.
Also referred to as Sprix.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥18 years old
- English-speaking
- Candidate for unilateral ureteroscopy for treatment of urolithiasis
- Surgical plan includes placement of a ureteral stent
You likely can't join if
- 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
See the full eligibility criteria
- ≥18 years old
- English-speaking
- Candidate for unilateral ureteroscopy for treatment of urolithiasis
- Surgical plan includes placement of a ureteral stent
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.