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NCT Number: NCT06860711

Safety of Short-course of NSAIDs in Pediatric Patients With CKD

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric Urology Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 month–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Gemma Beltran, MPH

CONTACT

[email protected]

Jennifer Pyrzanowski, MSPH

CONTACT

[email protected]

4133295321

Kyle Rove, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NSAIDs

Drug

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

Drug

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

Primary outcomes

  1. Frequency of Acute Kidney Injury

    Time frame: From start of intervention, through 14 days later

    Acute kidney injury (AKI) will be assessed for according to Kidney Disease Improving Global Outcomes (KDIGO) criteria. Specifically, an AKI will be defined as a serum creatinine increase of ≥ 1.5 times baseline or ≥0.3 mg/dl increase within 48hrs, or a urine output <0.5ml/kg/h for 6 to 12 hours. While there are 3 stages of AKI, the investigators will consider AKI a binary outcome since all stages are managed the same clinically. Urine output is recorded as a routine part of strict intake & output monitoring by nursing. The serum creatinine will be compared to the pre-incisional/baseline data.

Secondary outcomes

  1. Opiates received while inpatient

    Time frame: From start of intervention, through 7 days later

    Opiate use will be calculated as morphine equivalents per day, adjusted for weight.

  2. Days with elevated pain score

    Time frame: From start of intervention, through hospitalization up to 5 days

    Pain scores will be assessed using the Faces Pain Scale - Revised (FPS-R) or the visual analogue scale (VAS) depending on age, per nursing routine. The former is used for patients aged 4-8 years, and latter for patients aged 9 and older. These have previously been shown to be interchangeable. Both pain scales have a range from 0-10, with 10 being the worst. This metric will not be captured for patients under 4 years of age. The percentage of days with severe, or a pain score greater than 7 will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Pyrzanowski, MSPH

CONTACT

[email protected]

413-329-5321

Kyle Rove, MD

CONTACT

[email protected]

7209758206

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Safety of Short-term NSAID Use in the Postoperative Setting in Pediatric Patients With Chronic Kidney Disease

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 6, 2025
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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