NCT06860711

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Disease
• Pediatric Urology

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-07-22
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2025-03-06
• Last updated: 2025-10-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study