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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

Must not have

Patients on any steroid therapy

Patients with gastrointestinal ulcers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 to 2 months post stent removal

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.

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.

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

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I am planning to have a stent placed in my ureter after a procedure for kidney stones.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking steroid medication.

Select...

I have a stomach or intestinal ulcer.

Select...

I do not have an active urinary tract infection.

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I need a procedure for stones in both kidneys.

Select...

I have a blockage or narrowing in my ureter not caused by kidney stones.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 to 2 months post stent removal

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

0 / 6Eligibility criteria met