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
University of Colorado, Denver
80 participants
Jul 22, 2025
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
Inclusion Criteria2
- Patients over 18 months of age
- diagnosis of CKD stages 2-3a, confirmed by cystatin C laboratory testing within 6 months of surgery
Exclusion Criteria9
- diagnosis of CKD stage 1 or 4-5
- home medications of angiotensin converting enzyme inhibitors (ACEi, such as lisinopril or captopril) or angiotensin receptor blocker (ARB, such as losartan, valsartan) diuretics, or trimethoprim
- IV contrast in last 30 days
- PMH of renal transplant, diabetes, hypertension, nephrotic syndrome or heart failure, asthma, or hyperthyroidism
- history of hyperkalemia
- recent glucocorticoid exposure
- procedure for oncologic indications
- ongoing viral or fungal infection, or chemotherapy
- allergy to NSAIDs
Interventions
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.
IV or PO medication, compounded to have similar look, consistency and taste to the corresponding medications
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06860711