[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100421696":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":61,"collaborators":11,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":11,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":11,"enrollmentInfo":73,"targetDuration":11,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":11,"overallStatus":45,"whyStopped":11,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"The University of Texas Health Science Center, Houston","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group (Ketorolac)","EXPERIMENTAL",null,[13],"Drug: Ketorolac",{"label":15,"type":16,"description":11,"interventionNames":17},"Control Group","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Ketorolac","Ketorolac 0.5mg\u002Fkg will be administered intra-operatively at the conclusion of the case and 3 more doses scheduled every 8 hours in the first 24 hours post-operatively for a total of 4 doses of Ketorolac",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Placebo","0.9% Normal Saline will be administered intra-operatively at the conclusion of the case and 3 more doses scheduled every 8 hours in the first 24 hours post-operatively for a total of 4 doses of normal saline.",[15],[30],{"name":31,"affiliation":5,"role":32},"Matthew R Grieves, MD,MS,FACS","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"Matthew R Greives, MD,MS,FACS","CONTACT","(713) 500-7275","Matthew.R.Greives@uth.tmc.edu",{"name":40,"role":36,"phone":11,"phoneExt":11,"email":41},"Tien Do, DO","Tien.Do@uth.tmc.edu",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"The University of Texas Health Science Center at Houston","RECRUITING","Houston","Texas","77030","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-95.36327,29.76328,{"lat":55,"lon":54},[58,60],{"name":35,"role":36,"phone":59,"phoneExt":11,"email":38},"713-500-7275",{"name":40,"role":36,"phone":11,"phoneExt":11,"email":41},{"type":32,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Matthew Greives","Associate Professor","100421696","phase-4-ketorolac-in-palatoplasty-100421696",false,"NCT04771156","Ketorolac in Palatoplasty","Ketorolac in Palatoplasty: A Randomized Blinded Controlled Trial.","Inclusion Criteria:\n\n-Patient with Cleft palate (Complete and incomplete), with or without cleft lip, unilateral or bilateral\n\nExclusion Criteria:\n\n* Syndromic Cleft Palate patients\n* Previous palatoplasty\n* Major unrepaired cardiac malformation\n* History of GI complications (GI Bleed, Gastric Ulceration)\n* History of Renal disorder\n* History of coagulopathy (As contraindication to NSAID use)\n* Feeding tube dependency\n* Patients whose parents refuse to consent to randomization","ALL","6 Months",{"count":74,"type":75},74,"ESTIMATED","INTERVENTIONAL",[78],"PHASE4","The purpose of this study is to see if the addition of IV Ketorolac to usual care multi-modal pain therapy compared to usual care will improve oral intake post-operatively",[81],"Cleft Lip and Palate","2026-02-17",{"date":84,"type":85},"2026-02-19","ACTUAL",{"date":87,"type":85},"2021-09-17",{"date":89,"type":75},"2027-04-01",{"name":5,"class":6},1]