Recruiting
Early Phase 1

NSAIDs

Sponsor:

Washington University School of Medicine

Code:

NCT03638999

Conditions

Ureteral Stent Placement

Kidney Stone

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ketorolac Trometamol 30Mg/1mL Injection

Normal saline

Study Details

Brief 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.

Conditions

Ureteral Stent Placement

Kidney Stone

Study ID

NCT03638999

Start date

Jul 31, 2018

Status verified date

Dec, 2025

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Intervention Group - Ketorlac (NSAID)

Subjects will receive a one-time intravenous injection of 1 ml of Ketorlac 30 mg/ml prior to the start of the ureteroscopic procedure. After consent and during screening visit demographic information, medical/surgical history, and height and weight will be collected. On Day 0 subject will be randomized to NSAID or Saline using inclusion/exclusion criteria and the procedure data will be collected. On Day 1 subject will receive a follow up phone call and complete AUA Symptom Score, USS Questionnaire 1 and USS Questionnaire 2 and any adverse events will be assessed. These questionnaires will again be administered on the day of stent removal and again 1 to 2 months post stent removal.

placebo comparator: Placebo Group - Normal Saline

Subjects in the control group will receive a one-time 1 ml of 0.9% injectable normal saline prior to the start of the ureteroscopic procedure. After consent and during screening visit demographic information, medical/surgical history, and height and weight will be collected. On Day 0 subject will be randomized to NSAID or Saline using inclusion/exclusion criteria and the procedure data will be collected. On Day 1 subject will receive a follow up phone call and complete AUA Symptom Score, USS Questionnaire 1 and USS Questionnaire 2 and any adverse events will be assessed. These questionnaires will again be administered on the day of stent removal and again 1 to 2 months post stent removal.

Interventions

Ketorolac 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.

Normal saline

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

Primary outcome measure

  • Analog Pain Scale, 0 - 10 rating of pain - Stent insertion Day 1 [ Time Frame: Stent insertion Day 1 ]
  • Analog Pain Scale, 0 - 10 rating of pain - Stent removal [ Time Frame: Stent removal visit (Approximately 7 to 14 days) ]
  • Analog Pain Scale, 0 - 10 rating of pain - Follow-up Visit [ Time Frame: 1 to 2 months post stent removal ]

Central Contacts and Locations

Central contacts

Alana Desai, MD

(314)desaia@email.wustl.edu

Karla Bergeron, CCRP

(314) 454-7325bergeronk@email.wustl.edu

Locations

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Karla Bergeron

314-454-7325bergeronk@email.wustl.edu

Aleksandra Klim, RN, BSN

(314) 747-9781klima@wustl.edu

More Information

Sponsor

Washington University School of Medicine

Last update posted

Dec 22, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2025-12-22.