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RECRUITING
NCT06860711
PHASE4

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

Sponsor: University of Colorado, Denver

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Months - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-07-22

Completion Date

2027-06

Last Updated

2025-10-22

Healthy Volunteers

No

Interventions

DRUG

NSAIDs

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.

DRUG

Placebo

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