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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-22

Study Completion Date

2027-06-30

Brief Summary

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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 will be a limited pilot study within a Pediatric Urology population, intended to inform future work in a larger patient population.

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Detailed Description

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Conditions

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Chronic Kidney Disease Pediatric Urology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

NSAIDs

Intervention Type 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

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No