NSAIDs Stent Study

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a pilot study to (1) evaluate the effect of Ketorolac on inflammatory response and its impact on stent related symptoms in patients undergoing stent placement procedure and (2) assess feasibility of recruitment, randomization, assessment procedures and implementation of the study intervention.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Ketorolac; Ketorolac Tromethamine

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.