Safety of Short-course of NSAIDs in Pediatric Patients With CKD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NSAIDs, Placebo.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease, Pediatric Urology. Basic parameters: 18 months — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Safety of Short-term NSAID Use in the Postoperative Setting in Pediatric Patients With Chronic Kidney Disease
Overview
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.
Interventions
- Drug 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. - Drug Placebo
IV or PO medication, compounded to have similar look, consistency and taste to the corresponding medications
Primary outcome measures
- Frequency of Acute Kidney Injury [Time frame: From start of intervention, through 14 days later]
Secondary outcome measures (2)
- Opiates received while inpatient [Time frame: From start of intervention, through 7 days later]
- Days with elevated pain score [Time frame: From start of intervention, through hospitalization up to 5 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Children's Hospital Colorado — Aurora
Publications
- Ha D, Halstead NV, Blanchette ED, Wilcox DT, Vemulakonda VM, Wood DN, Rove KO. Risk of acute kidney injury after lower urinary tract reconstruction with early NSAID therapy: A propensity matched retrospective analysis. J Pediatr Urol. 2024 Oct;20(5):911-920. doi: 10.1016/j.jpurol.2024.07.005. Epub 2024 Jul 16. PMID 39089953
Identifiers
NCT: NCT06860711 · 24-1252