NSAIDs Stent Study
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Ketorolac Trometamol 30Mg/1mL Injection
- Normal saline
Treatment groups
36 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov