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

University of Colorado Denver (CU Denver)

Status and phase: Enrolling; Phase 4

Conditions: Chronic Kidney Disease; Pediatric Urology

Treatments: Drug: NSAIDs; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06860711

24-1252

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

NSAID

Experimental group

Description:

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.

Treatment:

Drug: NSAIDs

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo