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Ketorolac Injection for Kidney Stones

Phase < 1
Recruiting
Led By Alana Desai, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with renal urolithiasis planning to undergo ureteral stent placement following ureteroscopic manipulation
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 to 2 months post stent removal
Awards & highlights

Study Summary

This trial is studying whether the drug Ketorolac can help reduce symptoms related to stents.

Who is the study for?
Adults over 18 planning to have a stent placed for kidney stones can join. They must be able to consent and not be on steroids, have GI ulcers, or liver/kidney issues. Pregnant women, those with existing stents or certain other health problems are excluded.Check my eligibility
What is being tested?
The study is testing if Ketorolac, an anti-inflammatory drug given as an injection, can reduce symptoms after ureteral stent placement compared to a saline solution. It's also checking how easy it is to run the trial.See study design
What are the potential side effects?
Ketorolac may cause stomach pain, bleeding in the stomach or intestines, kidney problems, dizziness and swelling due to fluid retention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am planning to have a stent placed in my ureter after a procedure for kidney stones.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 to 2 months post stent removal
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 to 2 months post stent removal for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Analog Pain Scale, 0 - 10 rating of pain - Follow-up Visit
Analog Pain Scale, 0 - 10 rating of pain - Stent insertion Day 1
Analog Pain Scale, 0 - 10 rating of pain - Stent removal

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Intervention Group - Ketorlac (NSAID)Active Control1 Intervention
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.
Group II: Placebo Group - Normal SalinePlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,945 Previous Clinical Trials
2,303,780 Total Patients Enrolled
Alana Desai, MDPrincipal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
5 Total Patients Enrolled

Media Library

Intervention Group - Ketorlac (NSAID) Clinical Trial Eligibility Overview. Trial Name: NCT03638999 — Phase < 1
Ureteral Stent Placement Research Study Groups: Intervention Group - Ketorlac (NSAID), Placebo Group - Normal Saline
Ureteral Stent Placement Clinical Trial 2023: Intervention Group - Ketorlac (NSAID) Highlights & Side Effects. Trial Name: NCT03638999 — Phase < 1
Intervention Group - Ketorlac (NSAID) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03638999 — Phase < 1
~1 spots leftby Oct 2024
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