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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06860711
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Months - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Jul 22, 2025
Status verified
Oct 2025
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
164 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045
Jennifer Pyrzanowski, MSPH
[email protected]
4133295321
Gemma Beltran, MPH
[email protected]
Kyle Rove, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By condition
Chronic kidney disease
By specialty
NephrologyKidney disease
By research site
Children's Hospital Colorado· Aurora, CO

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