Short-course NSAID safety after surgery in children with chronic kidney disease
Official title: Safety of Short-term NSAID Use in the Postoperative Setting in Pediatric Patients With Chronic Kidney Disease
Run by University of Colorado, Denver · NCT06860711 · Data updated 2026-11-12
This trial will test whether short courses of NSAIDs after surgery increase the risk of acute kidney injury in children with mild-to-moderate chronic kidney disease.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Months to 25 Years |
| Sex | All |
| Enrollment | 164 (estimated) |
| Sponsor | University of Colorado, Denver Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Aurora, Colorado) |
| Status | Recruiting |
| Started | July 22, 2025 |
| Main results expected | June 2028 |
| Study ends | December 2028 |
| Registry record updated | June 8, 2026 |
| Trial ID | NCT06860711 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children older than 18 months undergoing non-oncologic pediatric urologic surgery with CKD stage 2-3a confirmed by recent cystatin C and not taking excluded medications are ideal candidates.
✕Probably not a fit
Patients with CKD stage 1 or 4-5, those on ACEi/ARBs/diuretics/trimethoprim, with prior transplant, diabetes, hypertension, nephrotic syndrome, heart failure, recent IV contrast, active infections, or NSAID allergy are excluded and would not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a limited Phase 4 pilot randomized trial in a pediatric urology postoperative population comparing short-course NSAIDs to placebo for pain management. Eligible participants are children older than 18 months with CKD stage 2-3a confirmed by cystatin C within six months and without major comorbidities or contraindicated medications. The study excludes patients on ACE inhibitors/ARBs, diuretics, or trimethoprim, as well as those with prior transplant, diabetes, hypertension, nephrotic syndrome, heart failure, recent IV contrast, active infections, or NSAID allergy. Results are intended to inform safety and design of larger studies about perioperative NSAID use in pediatric CKD.
Why it matters
Potential benefit: If safe, this could support using short-course NSAIDs for postoperative pain in children with CKD and potentially reduce reliance on opioids.
How similar studies have gone: Adult studies and observational pediatric reports suggest NSAIDs can increase AKI risk, but randomized controlled data specifically in children with CKD are limited, making this a relatively novel pilot.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 18 months of age * diagnosis of CKD stages 2-3a, confirmed by CKiD U25 eGFR calculator based on cystatin C laboratory testing within 6 months of surgery * Patient is scheduled to undergo a urologic surgery requiring admission or overnight stay in the hospital Exclusion Criteria: * Diagnosis of CKD stage 1 or 4-5 * Past medical history of renal transplant * Past medical history of nasal polyp * Procedure for oncologic indications or on chemotherapy * Pregnant patient * True allergy to NSAIDs
Where it's running
-
Children's Hospital Colorado
Aurora, Colorado, United States Recruiting
Study contacts
- Principal investigator: Kyle Rove, MD — Children's Hospital Colorado
- Study coordinator: Kyle Rove, MD
- Email: kyle.rove@childrenscolorado.org
- Phone: 7209758206
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.