Short-course NSAID safety after surgery in children with chronic kidney disease
Safety of Short-term NSAID Use in the Postoperative Setting in Pediatric Patients With Chronic Kidney Disease
PHASE4 · University of Colorado, Denver · NCT06860711
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 | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Months and up |
| Sex | All |
| Sponsor | University of Colorado, Denver (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06860711 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 18 months of age * diagnosis of CKD stages 2-3a, confirmed by cystatin C laboratory testing within 6 months of surgery Exclusion Criteria: * 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
Where this trial is running
Aurora, Colorado
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Kidney Disease, Pediatric Urology, NSAIDs, CKD, Pediatrics, Urology, post-surgical