Could a simple pain shot before surgery make stent recovery easier?
NCT ID NCT03638999
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study is testing whether a single injection of ketorolac (Toradol), given just before ureteral stent placement, can reduce pain and inflammation afterward. About 36 adults undergoing kidney stone surgery will be randomly assigned to receive either ketorolac or a placebo (saline). Researchers will measure pain levels on a 0–10 scale at several time points and also check if the study procedures are practical for a larger trial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ketorolac (Toradol) injection
- What this could lead to
- If it works, this could point toward a simple, low-cost way to reduce pain and discomfort for people with ureteral stents after kidney stone surgery.
- What could go wrong
- This is a very early, small pilot study with only 36 participants. The results may not be strong enough to change practice, and ketorolac carries risks like bleeding or kidney issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2018
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Washington University
RECRUITINGSt Louis, Missouri, 63110, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New flexible suction sheath may improve kidney stone removal in children
- Could your diet trigger kidney stones by changing your immune system?