Safety of Short-course of NSAIDs in Pediatric Patients With CKD
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-25
SponsorUniversity of Colorado, Denver
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
NSAIDs
DrugIV 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
DrugIV or PO medication, compounded to have similar look, consistency and taste to the corresponding medications
Treatment groups
164 Participants
are divided into 2 treatment groupsGroup A: NSAIDExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Frequency of Acute Kidney Injury
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 ≥0.3 mg/dl increase within 48hrs, 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.
Time frame
From start of intervention, through 14 days laterSecondary outcomes
1
Opiates received while inpatient
Opiate use will be calculated as morphine equivalents per day, adjusted for weight.
Time frame
From start of intervention, through 7 days later2
Days with elevated pain score
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.
Time frame
From start of intervention, through hospitalization up to 5 daysSponsors and contacts
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Source ClinicalTrials.gov