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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Ketorolac Trometamol 30Mg/1mL Injection
DrugSubjects in the intervention group will receive intravenous injection of 1 ml of Ketorlac 30 mg/ml prior to the start of the ureteroscopic procedure.
Normal saline
DrugSubjects in the control group will receive 1 ml of 0.9% injectable normal saline prior to the start of the ureteroscopic procedure.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Intervention Group - Ketorlac (NSAID)Active comparator 1 intervention
Group B: Placebo Group - Normal SalinePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Analog Pain Scale, 0 - 10 rating of pain - Stent insertion Day 1
The Analog Pain Scale is a patient reported scale from 0-10 that will be administered after standard surgical procedure of ureteroscopy with or without laser lithotripsy and/or stone extraction). The Analog Pain Scale uses 0 (zero) to describe no pain and 10 will reference worst pain.
Time frame
Stent insertion Day 12
Analog Pain Scale, 0 - 10 rating of pain - Stent removal
The Analog Pain Scale is a patient reported scale from 0-10 that will be administered during the stent removal visit. The Analog Pain Scale uses 0 (zero) to describe no pain and 10 will reference worst pain.
Time frame
Stent removal visit (Approximately 7 to 14 days)3
Analog Pain Scale, 0 - 10 rating of pain - Follow-up Visit
The Analog Pain Scale is a patient reported scale from 0-10 that will be administered during follow up visit. The Analog Pain Scale uses 0 (zero) to describe no pain and 10 will reference worst pain.
Time frame
1 to 2 months post stent removalSponsors and contacts
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Source ClinicalTrials.gov