NSAIDs Stent Study

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT03638999
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Kidney Stone
  • Ureteral Stent Placement

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ketorolac Trometamol 30Mg/1mL Injection — DRUG
    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 — DRUG
    Subjects in the control group will receive 1 ml of 0.9% injectable normal saline prior to the start of the ureteroscopic procedure.

Study Details

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.

Key Dates

Start date
Jul 31, 2018
Status verified
Dec 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

Analog Pain Scale, 0 - 10 rating of pain - Stent insertion Day 1 [ Time Frame: Stent insertion Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington UniversitySt LouisMissouri63110
Karla Bergeron
[email protected]
314-454-7325
Aleksandra Klim, RN, BSN
[email protected]
(314) 747-9781

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By research site
Washington University· St Louis, MO

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