A Prospective, Randomized, Pilot Study of Preoperative Anti-Inflammatory Therapy for Ureteral Stent Symptoms
Washington University School of Medicine
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.
Description
Ureteral stent is routinely placed following ureteroscopic procedures to aid in urinary drainage post-operatively. Up to 80% of patients, however, experience stent-related symptoms (SRS) including lower abdominal pain, burning with urination, blood in urine and voiding symptoms affecting activities of their daily living. Intra- and/or post-operative therapeutic options are limited and most are initiated following the ureteral stent placement when the inflammatory process has already begun from ureteral manipulation, further limiting their efficacy. We, therefore, hypothesize that pre-operative…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 d…
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.
Location
- Washington UniversitySt Louis, Missouri