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

Phase 4

Not yet recruiting

• Conditions: Chronic Kidney Disease; Pediatric Urology
• Interventions: Drug: NSAIDs; Drug: Placebo

• Registration Number: NCT06860711
• Lead Sponsor: University of Colorado, Denver

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-28
• Study First Submitted QC: 2025-02-28
• Status Verified: 2025-03
• Study Start: 2025-03
• Study First Posted: 2025-03-06
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-11
• Primary Completion: 2027-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NSAID	NSAIDs	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	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 Measures

Name	Time	Method
Frequency of Acute Kidney Injury	From start of intervention, through 7 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 ≥3 mg/dl increase, 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 Outcome Measures

Name	Time	Method
Opiates received while inpatient	From start of intervention, through 7 days later	Opiate use will be calculated as morphine equivalents per day, adjusted for weight.
Days with elevated pain score	From start of intervention, through 7 days later	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.

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States