[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582238":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":22,"studyPopulation":22,"armGroups":34,"interventions":47,"overallOfficials":56,"centralContacts":61,"locations":70,"responsibleParty":92,"collaborators":22,"id":94,"slug":22,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":22,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":22,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":72,"whyStopped":22,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"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\u002Fdl increase within 48hrs, or a urine output \\\u003C0.5ml\u002Fkg\u002Fh 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\u002Fbaseline data.","From start of intervention, through 14 days later",[14,18],{"measure":15,"description":16,"timeFrame":17},"Opiates received while inpatient","Opiate use will be calculated as morphine equivalents per day, adjusted for weight.","From start of intervention, through 7 days later",{"measure":19,"description":20,"timeFrame":21},"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.","From start of intervention, through hospitalization up to 5 days",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":22,"primaryPurpose":26,"observationalModel":22,"timePerspective":22,"maskingInfo":27},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":28,"maskingDescription":22,"whoMasked":29},"QUADRUPLE",[30,31,32,33],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[35,41],{"label":36,"type":37,"description":38,"interventionNames":39},"NSAID","EXPERIMENTAL","Participants will receive an intravenous (IV) ketorolac 0.5mg\u002Fkg\u002Fdose, 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\u002Fkg\u002Fdose, 400mg maximum. The total duration of intervention (IV + PO) will not exceed 5 days.",[40],"Drug: NSAIDs",{"label":42,"type":43,"description":44,"interventionNames":45},"Placebo","PLACEBO_COMPARATOR","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.",[46],"Drug: Placebo",[48,53],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":22},"DRUG","NSAIDs","IV formulation: ketorolac 0.5mg\u002Fkg\u002Fdose, 15mg maximum, no more than 8 doses total PO formulation: ibuprofen suspension 10mg\u002Fkg\u002Fdose, 400mg maximum Total duration (IV + PO) will not exceed 5 days.",[36],{"type":49,"name":42,"description":54,"armGroupLabels":55,"otherNames":22},"IV or PO medication, compounded to have similar look, consistency and taste to the corresponding medications",[42],[57],{"name":58,"affiliation":59,"role":60},"Kyle Rove, MD","Children's Hospital Colorado","PRINCIPAL_INVESTIGATOR",[62,66],{"name":58,"role":63,"phone":64,"phoneExt":22,"email":65},"CONTACT","7209758206","kyle.rove@childrenscolorado.org",{"name":67,"role":63,"phone":68,"phoneExt":22,"email":69},"Jennifer Pyrzanowski, MSPH","413-329-5321","Jennifer.pyrzanowski@cuanschutz.edu",[71],{"facility":59,"status":72,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"RECRUITING","Aurora","Colorado","80045","United States","US",{"type":79,"coordinates":80},"Point",[81,82],-104.83192,39.72943,{"lat":82,"lon":81},[85,88,91],{"name":67,"role":63,"phone":86,"phoneExt":22,"email":87},"4133295321","jennifer.pyrzanowski@cuanschutz.edu",{"name":89,"role":63,"phone":22,"phoneExt":22,"email":90},"Gemma Beltran, MPH","gemma.beltran@cuanschutz.edu",{"name":58,"role":60,"phone":22,"phoneExt":22,"email":22},{"type":93,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100582238",false,"NCT06860711","Safety of Short-course of NSAIDs in Pediatric Patients With CKD","Safety of Short-term NSAID Use in the Postoperative Setting in Pediatric Patients With Chronic Kidney Disease","Inclusion Criteria:\n\n* Patients over 18 months of age\n* diagnosis of CKD stages 2-3a, confirmed by CKiD U25 eGFR calculator based on cystatin C laboratory testing within 6 months of surgery\n* Patient is scheduled to undergo a urologic surgery requiring admission or overnight stay in the hospital\n\nExclusion Criteria:\n\n* Diagnosis of CKD stage 1 or 4-5\n* Past medical history of renal transplant\n* Past medical history of nasal polyp\n* Procedure for oncologic indications or on chemotherapy\n* Pregnant patient\n* True allergy to NSAIDs","ALL","18 Months","25 Years",{"count":104,"type":105},164,"ESTIMATED","INTERVENTIONAL",[108],"PHASE4","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.",[111,112],"Chronic Kidney Disease","Pediatric Urology",[50,114,115,116,117],"CKD","Pediatrics","Urology","post-surgical","2026-06-04",{"date":120,"type":121},"2026-06-08","ACTUAL",{"date":123,"type":121},"2025-07-22",{"date":125,"type":105},"2028-12",{"name":5,"class":6},1]