[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100365606":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":57,"collaborators":25,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Phoenix Children's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL","1. Description: Patients randomized for the treatment arm of the study group will receive a continuous infusion of ketorolac plus an intermittent dose of placebo (plasmalyte). To eliminate excess exposure and the associated side effects, all patients enrolled in the study will not be given any additional NSAIDs (except aspirin, which is standard of care in many post-operative cardiac surgery patients) during the study period.\n2. Dosage and Route of Administration:\n\n   1. Continuous ketorolac 0.08mg\u002Fkg\u002Fhr, with a maximum of 5mg\u002Fhr for patients weighing greater than or equal to 60kg, administered intravenously by nursing staff. Study drug will infuse continuously for 48 hours.\n   2. Intermittent Plasmalyte 0.033mL\u002Fkg (max 2mL) infusion every 6 hours for 48 hours.",[13],"Drug: Continuous ketorolac",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of care","PLACEBO_COMPARATOR","1. Description: Patients randomized to the standard of care arm of the study will receive a generically marked syringe of Plasmalyte to be infused at the same rate as the treatment medication, and will only receive intermittent dosing of ketorolac (current standard of care). As in the treatment group, no additional NSAIDs (except aspirin) are to be given during the 48 hour study period.\n2. Dosage and Route of Administration\n\n   1. Continuous Plasmalyte infusion to match the aforementioned ketorolac dosing\n   2. Intermittent ketorolac 0.5mg\u002Fkg IV infusion every 6 hours (max 30mg per dose)",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Continuous ketorolac","Patients randomized for the treatment arm of the study group will receive a continuous infusion of ketorolac plus an intermittent dose of placebo (plasmalyte) for 48 hours.",[15,9],null,[27],{"name":28,"affiliation":29,"role":30},"Kevin Engelhardt, MD","Heart Center","PRINCIPAL_INVESTIGATOR",[32,36],{"name":28,"role":33,"phone":34,"phoneExt":25,"email":35},"CONTACT","6029333366","kengelhardt@phoenixchildrens.com",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Samantha Stack, BS","6029330607","sstack@phoenixchildrens.com",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Phoenix","Arizona","85016","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-112.07404,33.44838,{"lat":52,"lon":51},[55,56],{"name":28,"role":33,"phone":34,"phoneExt":25,"email":35},{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},{"type":58,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100365606","phase-4-continuous-vs-intermittent-ketorolac-for-pain-control-in-peds-cv-surgery-100365606",false,"NCT04040452","Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery","Continuous Infusion Versus Intermittent Ketorolac for Postoperative Pain Control in Pediatric Cardiac Surgery Patients","CIVIK","Inclusion Criteria:\n\n1. All patients aged 3 months to 4 years 11months admitted post operatively to the CVICU during the time period in which the study will be ongoing\n2. Initiation of study medication within the first 12-24 hours post-operatively\n3. The cardiovascular attending of record after review of the intraoperative course and post-operative laboratories determines the patient will receive Ketorolac for pain control\n\nExclusion Criteria:\n\n1. Patients that have acute kidney injury, as defined by the letter \"I\" in the pRIFLE criteria.\n2. History of allergy or sensitivity reaction to ketorolac or any NSAID medications.\n3. Requiring mechanical circulatory support (ECMO) or continuous renal replacement therapy (CRRT) within the first 48 hours post-operatively\n4. Orthotopic heart transplantation\n5. Clinically significant bleeding\n6. Patients with known pre-operative medical renal disease, renal transplantation history, congenital or acquired renal abnormality or deformity","ALL","3 Months","59 Months",{"count":71,"type":72},166,"ESTIMATED","INTERVENTIONAL",[75],"PHASE4","The proposed study will be a prospective, randomized, double blind, placebo controlled trial to compare the use of a continuous infusion versus intermittent ketorolac on postoperative patients in the pediatric cardiovascular ICU. We intend to determine if the continuous infusion leads to a decreased utilization of opiates when compared to intermittent ketorolac.",[78],"Congenital Heart Disease in Children",[80,81,82,83,84,85],"pain control","cardiac surgery","pediatric","opioid","NSAID","congenital heart disease","2026-04-22",{"date":88,"type":89},"2026-04-27","ACTUAL",{"date":91,"type":89},"2021-03-01",{"date":93,"type":72},"2026-12-01",{"name":5,"class":6},1]