Evaluating Ketorolac for reducing symptoms after ureteral stent placement
A Prospective, Randomized, Pilot Study of Preoperative Anti-Inflammatory Therapy for Ureteral Stent Symptoms
This study is testing if giving a pain medication called Ketorolac before placing a ureteral stent can help reduce discomfort and inflammation for people with kidney stones.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT03638999 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess the effectiveness of pre-operative intravenous Ketorolac in reducing inflammatory responses and stent-related symptoms in patients undergoing ureteral stent placement due to kidney stones. Eligible participants will be randomly assigned to receive either Ketorolac or a saline control before their procedure. The study will also evaluate the feasibility of recruitment and assessment procedures, alongside measuring plasma inflammatory markers at various stages. Follow-up will include a post-operative check-in to monitor patient recovery and adherence to the protocol.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with renal urolithiasis scheduled for ureteral stent placement.
Not a fit: Patients with chronic NSAID use, active urinary tract infections, or those requiring bilateral stone procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce post-operative discomfort and improve recovery for patients undergoing ureteral stent placement.
How similar studies have performed: While the use of Ketorolac in this specific context is novel, similar studies have shown promise in reducing inflammation and pain in other surgical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Over 18 years of age and willing and able to provide informed consent * Patients with renal urolithiasis planning to undergo ureteral stent placement following ureteroscopic manipulation Exclusion Criteria: * Patients requiring a bilateral stone procedure. * Patients on a chronic non-steroidal anti-inflammatory drugs (NSAIDs) including Aspirin defined as any NSAIDs use for more than fifteen days within thirty days prior to the procedure. Exception: use of daily Aspirin 81 mg is allowed. * Patients on any steroid therapy. * Patients with prescription anti-inflammatory drugs. * Patients with gastrointestinal ulcers. * Patients with ureteral obstruction or stricture unrelated to stone disease. * Patients with active urinary tract infection as evidence of untreated positive urine culture obtained prior to the procedure (as part of pre-operative testing). * Patients with preexisting indwelling ureteral stent * Patients who are pregnant or lactating. * Patients with renal or liver impairment. * Patients with concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would render the patient inappropriate for enrollment.
Where this trial is running
St Louis, Missouri
- Washington University — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Alana Desai, MD — Washington University School of Medicine
- Study coordinator: Alana Desai, MD
- Email: desaia@email.wustl.edu
- Phone: (314)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.