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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
Over 18 years of age and willing and able to provide informed consent
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.
Select...
I am over 18 and can give my consent.

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
1,928 Previous Clinical Trials
2,296,927 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have signed up to partake in this research?

"Affirmative, according to the information held on clinicaltrials.gov this study is actively looking for participants. It was initially posted on July 31st 2018 and last updated November 22nd 2022. They require 36 patients from a single medical centre."

Answered by AI

What additional testing has been carried out in relation to Intervention Group - Ketorlac (NSAID)?

"Currently, 8 Phase 3 trials involving the use of ketorlac (NSAID) are underway. Most studies have been established in Los Angeles but there are 57 additional sites participating in these clinical investigations."

Answered by AI

What indications has Ketorlac (NSAID) been found to be most efficacious in treating?

"Intervention Group - Ketorlac (NSAID) can be administered to alleviate ocular itching, pain, and the formation of nerve block."

Answered by AI

Are there any existing opportunities for participation in this research?

"According to clinicaltrials.gov, this research endeavor is currently recruiting participants; the trial was first advertised on July 31st 2018 and was last revised November 22nd 2022."

Answered by AI
Recent research and studies
~3 spots leftby Oct 2024