RecruitingPhase 4NCT06860711

Safety of Short-course of NSAIDs in Pediatric Patients With CKD

Safety of Short-term NSAID Use in the Postoperative Setting in Pediatric Patients With Chronic Kidney Disease


Sponsor

University of Colorado, Denver

Enrollment

80 participants

Start Date

Jul 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to determine if non-steroidal anti-inflammatory (NSAID) use in the postoperative setting increases the risk of acute kidney injury (AKI) in pediatric patients with mild-to-moderate chronic kidney disease (CKD). The investigators hypothesize that there is no increased risk. This will be a limited pilot study within a Pediatric Urology population, intended to inform future work in a larger patient population.


Eligibility

Min Age: 18 Months

Plain Language Summary

Simplified for easier understanding

This study is looking at whether short-term use of anti-inflammatory pain medicines (like ibuprofen, called NSAIDs) is safe for children who have mild-to-moderate chronic kidney disease (CKD) and are recovering from surgery. **You may be eligible if...** - Your child is over 18 months of age - Your child has been diagnosed with CKD stages 2 or 3a, confirmed by a lab test called cystatin C in the past 6 months **You may NOT be eligible if...** - Your child has CKD stage 1 or stages 4–5 - Your child takes certain blood pressure medicines (ACE inhibitors or ARBs), diuretics, or trimethoprim - Your child received IV contrast dye in the past 30 days - Your child has a history of kidney transplant, diabetes, high blood pressure, asthma, or thyroid problems - Your child has had high potassium levels, recent steroid use, an active infection, or an allergy to NSAIDs - Surgery is being done for cancer-related reasons Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNSAIDs

IV formulation: ketorolac 0.5mg/kg/dose, 15mg maximum, no more than 8 doses total PO formulation: ibuprofen suspension 10mg/kg/dose, 400mg maximum Total duration (IV + PO) will not exceed 5 days.

DRUGPlacebo

IV or PO medication, compounded to have similar look, consistency and taste to the corresponding medications


Locations(1)

Children's Hospital Colorado

Aurora, Colorado, United States

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NCT06860711


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