Recruiting

NSAID

Sponsor:

University of Colorado, Denver

Code:

NCT06860711

Conditions

Chronic Kidney Disease

Pediatric Urology

Eligibility Criteria

Sex: All

Age: 1 - 25

Healthy Volunteers: Not accepted

Interventions

NSAIDs

Placebo

Study Details

Brief 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 is currently in the process of developing multi institution collaboration within a Pediatric Urology population, intended to inform future work in a larger patient population.

Conditions

Chronic Kidney Disease

Pediatric Urology

Study ID

NCT06860711

Start date

Jul 22, 2025

Status verified date

Oct, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 25

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

164 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NSAID

Participants will receive an intravenous (IV) ketorolac 0.5mg/kg/dose, 15mg maximum, for no more than 8 doses in keeping with the investigators' routine clinical practice. Participants will then receive the oral (PO) ibuprofen suspension 10mg/kg/dose, 400mg maximum. The total duration of intervention (IV + PO) will not exceed 5 days.

placebo comparator: Placebo

The IV formulation will be Normal Saline. The PO formulation will be compounded to have a similar look, volume, consistency and taste to the experimental medication. Participants will receive the IV formulation for no more than 8 doses. Participants will then receive the PO formulation. The total duration of intervention (IV + PO) will not exceed 5 days.

Interventions

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.

Placebo

IV or PO medication, compounded to have similar look, consistency and taste to the corresponding medications

Primary outcome measure

  • Frequency of Acute Kidney Injury [ Time Frame: From start of intervention, through 14 days later ]

Central Contacts and Locations

Central contacts

Kyle Rove, MD

7209758206kyle.rove@childrenscolorado.org

Jennifer Pyrzanowski, MSPH

413-329-5321Jennifer.pyrzanowski@cuanschutz.edu

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Jennifer Pyrzanowski, MSPH

4133295321jennifer.pyrzanowski@cuanschutz.edu

Gemma Beltran, MPH

gemma.beltran@cuanschutz.edu

Principal Investigator:

Kyle Rove, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jun 8, 2026

Last verified

Oct, 2025

Keywords

  • NSAIDs
  • CKD
  • Pediatrics
  • Urology
  • post-surgical

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-06-08.