[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640453":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":67,"collaborators":10,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":10,"studyType":82,"phases":10,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":49,"whyStopped":10,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University Hospital, Ghent","OTHER",[8,14],{"label":9,"type":10,"description":10,"interventionNames":11},"Standard of Care Paracetamol or Cefazolin treatment in children with normal weight",null,[12,13],"Drug: Cefazolin","Drug: Paracetamol (drug)",{"label":15,"type":10,"description":10,"interventionNames":16},"Standard of Care Paracetamol or Cefazolin treatment in children with overweight",[12,13],[18,25],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Cefazolin","Prophylactic Cefazolin treatment per standard-of-care",[9,15],[24],"Cephazolin",{"type":19,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Paracetamol (drug)","Preoperative dose of paracetamol, as per standard-of-care",[9,15],[30],"Acetaminophen",[32],{"name":33,"affiliation":34,"role":35},"Anca Amza","Ghent University Hospital and Ghent Univeristy","STUDY_DIRECTOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":10,"email":41},"Pieter De Cock, Prof. Apr","CONTACT","+32 9 332 29 69","pieter.decock@uzgent.be",{"name":43,"role":39,"phone":44,"phoneExt":10,"email":45},"Annemie Bauters, MD.","+ 32 9 332 18 83","Annemie.Bauters@UGent.be",[47],{"facility":48,"status":49,"city":50,"state":10,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Ghent University Hospital, Ghent","RECRUITING","Ghent","9000","Belgium","BE",{"type":55,"coordinates":56},"Point",[57,58],3.71667,51.05,{"lat":58,"lon":57},[61,64],{"name":33,"role":39,"phone":62,"phoneExt":10,"email":63},"+32 9 332 18 83","anca.amza@uzgent.be",{"name":65,"role":66,"phone":10,"phoneExt":10,"email":10},"Pieter De Cock, Prof. Apr.","PRINCIPAL_INVESTIGATOR",{"type":68,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100640453","paracetamol-and-cefazolin-pharmacokinetics-in-normal-weight-and-overweight-children-100640453",false,"NCT07585487","Paracetamol and Cefazolin Pharmacokinetics in Normal Weight and Overweight Children","TISSUE","Inclusion Criteria:\n\n* Patient admitted to the operating room for minor elective surgery\n* Patients undergoing general anesthesia for minor elective surgery\n* Patient age: children from 2 years to 15 years\n* Patients receiving cefazolin or paracetamol according to the standard procedure\n* Intra-arterial (preferred) or intravenous access available for blood sampling\n* BMI\n\nExclusion Criteria:\n\n* Personal or family history of excessive bleeding\n* Pre-existing coagulopathy and\u002For thrombocytopenia\n* No catheter available for blood sampling\n* Absence of parental consent\n* Known allergy to one of the components of the study\n* Pregnancy","ALL","2 Years","15 Years",{"count":80,"type":81},120,"ESTIMATED","OBSERVATIONAL","Pharmacokinetic evaluations will be conducted to characterize the cefazolin plasma concentration-time profile, cefazolin penetration into subcutaneous adipose tissue, and paracetamol metabolization as assessed through blood sampling. The study population consists of children aged 2 to 15 years with either normal weight or overweight. All participants are admitted for a minor elective surgical procedure and will receive paracetamol and\u002For cefazolin as part of standard perioperative care.\n\nDuring the procedure, multiple blood and tissue-fluid samples will be collected to quantify paracetamol and cefazolin concentrations in the bloodstream, as well as cefazolin concentrations in subcutaneous adipose tissue. The study aims to characterize drug concentration-time profiles in blood (paracetamol), plasma (cefazolin), and adipose tissue (cefazolin), and to compare these pharmacokinetic parameters between normal-weight and overweight children.\n\nThese data are essential to determine whether standard dosing regimens provide adequate drug exposure across different weight categories. Previous research indicates that achieving specific target concentrations in blood and tissue is necessary for optimal therapeutic effect, yet uncertainty remains regarding appropriate dosing in overweight children.",[85,20],"Paracetamol",[85,20,87,88],"Overweight","children","2026-05-08",{"date":91,"type":92},"2026-05-13","ACTUAL",{"date":94,"type":92},"2023-12-22",{"date":96,"type":81},"2027-01-30",{"name":5,"class":6},1]