RecruitingEarly Phase 1NCT03638999

NSAIDs Stent Study

A Prospective, Randomized, Pilot Study of Preoperative Anti-Inflammatory Therapy for Ureteral Stent Symptoms


Sponsor

Washington University School of Medicine

Enrollment

36 participants

Start Date

Jul 31, 2018

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether using non-steroidal anti-inflammatory drugs (NSAIDs) — common pain relievers like ibuprofen — after ureteral stent placement following kidney stone removal can reduce stent-related discomfort and pain. Ureteral stents are small tubes placed inside the ureter (the tube connecting the kidney to the bladder) after certain procedures to keep the urinary tract open and draining. Stent-related symptoms, including pain, urgency, and discomfort during urination, are extremely common and significantly affect quality of life. This trial will determine whether a short course of NSAIDs can effectively manage these symptoms. You may be eligible if: - You are over 18 years old - You have kidney stones and are planning to undergo ureteroscopic stone removal with ureteral stent placement You may NOT be eligible if: - You are having a procedure on both sides (bilateral) - You use NSAIDs regularly (more than 15 days in the past month, except aspirin 81 mg daily) - You take steroid or prescription anti-inflammatory medications - You have gastrointestinal ulcers, active urinary tract infection, or a pre-existing stent - You are pregnant or breastfeeding - You have kidney or liver problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKetorolac Trometamol 30Mg/1mL Injection

Subjects in the intervention group will receive intravenous injection of 1 ml of Ketorlac 30 mg/ml prior to the start of the ureteroscopic procedure.

DRUGNormal saline

Subjects in the control group will receive 1 ml of 0.9% injectable normal saline prior to the start of the ureteroscopic procedure.


Locations(1)

Washington University

St Louis, Missouri, United States

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NCT03638999


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