[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619083":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":50,"centralContacts":55,"locations":66,"responsibleParty":90,"collaborators":60,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":60,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":114,"overallStatus":69,"whyStopped":60,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"University Medical Centre Ljubljana","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Intramuscular Ketamine","ACTIVE_COMPARATOR","Participants assigned to this arm will receive intramuscular ketamine at a dose of 4 mg\u002Fkg body weight for analgosedation during suture removal after surgery for congenital clefts. In addition, glycopyrrolate 4 mcg\u002Fkg will be administered intramuscularly to reduce salivation. This arm represents the control group, following the established clinical protocol.",[13],"Drug: ketamine",{"label":15,"type":16,"description":17,"interventionNames":18},"Intranasal Nalbuphine","EXPERIMENTAL","Participants assigned to this arm will receive intranasal nalbuphine at a dose of 0.5 mg\u002Fkg body weight, administered using a mucosal atomizer device (MAD), for analgosedation during suture removal after cleft surgery. This intervention will be evaluated for its effectiveness, ease of administration, and safety compared with intramuscular ketamine.",[19],"Drug: Nalbuphine",{"label":21,"type":16,"description":22,"interventionNames":23},"Intranasal Dexmedetomidine","Participants assigned to this arm will receive intranasal dexmedetomidine at a dose of 3 mcg\u002Fkg body weight, administered using a mucosal atomizer device (MAD), for analgosedation during suture removal after cleft surgery. The intervention will be evaluated for sedation depth, response to separation from parents, and overall procedural ease compared with other sedative agents.",[24],"Drug: Dexmedetomidine",[26,35,42],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","ketamine","Intramuscular administration of Ketamine at 4 mg\u002Fkg body weight for analgosedation during suture removal in children after surgery for congenital clefts. Glycopyrrolate 4 mcg\u002Fkg will be co-administered to reduce salivation.",[9],[32,33,34],"Ketamine Hydrochloride","Ketanest","Ketalar",{"type":27,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Nalbuphine","Intranasal administration of Nalbuphine at 0.5 mg\u002Fkg body weight via mucosal atomizer device (MAD) for analgosedation during suture removal after cleft surgery in children.",[15],[40,41],"Nalbuphine Hydrochloride","Nubain",{"type":27,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Dexmedetomidine","Intranasal administration of Dexmedetomidine at 3 mcg\u002Fkg body weight via mucosal atomizer device (MAD) for analgosedation during suture removal after cleft surgery in children.",[21],[47,48,49],"Dexmedetomidine Hydrochloride","Precedex","Dexdor",[51],{"name":52,"affiliation":53,"role":54},"Tadej P Dovšak, DDS, MD, PhD","University Medical Centre Ljubljana, Department of Maxillofacial and Oral Surgery","STUDY_CHAIR",[56,62],{"name":57,"role":58,"phone":59,"phoneExt":60,"email":61},"Liljana Markova, MD, PhD","CONTACT","00 386 40 802 662",null,"liljana.markova@kclj.si",{"name":63,"role":58,"phone":64,"phoneExt":60,"email":65},"Eleonora Ivanova, MD","00 386 031 289 803","eleonora.ivanova@kclj.si",[67],{"facility":68,"status":69,"city":70,"state":60,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Department of Maxillofacial and Oral Surgery, University Medical Centre Ljubljana","RECRUITING","Ljubljana","1000","Slovenia","SI",{"type":75,"coordinates":76},"Point",[77,78],14.50513,46.05108,{"lat":78,"lon":77},[81,82,84,86,88],{"name":57,"role":58,"phone":59,"phoneExt":60,"email":61},{"name":63,"role":58,"phone":83,"phoneExt":60,"email":65},"00386 31 289 803",{"name":57,"role":85,"phone":60,"phoneExt":60,"email":60},"PRINCIPAL_INVESTIGATOR",{"name":63,"role":87,"phone":60,"phoneExt":60,"email":60},"SUB_INVESTIGATOR",{"name":89,"role":87,"phone":60,"phoneExt":60,"email":60},"Tadej Dovšak, MD, PhD",{"type":91,"investigatorFullName":60,"investigatorTitle":60,"investigatorAffiliation":60,"oldNameTitle":60,"oldOrganization":60},"SPONSOR","100619083","analgosedation-with-ketamine-nalbuphine-or-dexmedetomidine-for-suture-removal-in-children-after-cleft-surgery-100619083",false,"NCT07340008","Analgosedation With Ketamine, Nalbuphine, or Dexmedetomidine for Suture Removal in Children After Cleft Surgery","Comparison of Intramuscular Ketamine and Intranasal Nalbuphine and Dexmedetomidine for Analgosedation in Children Undergoing Suture Removal After Surgery for Congenital Clefts of the Palate, Alveolar Ridge, and Lip","KID-CLEFT","Inclusion criteria:\n\n* Age 6 months to 3 years\n* Scheduled for suture removal after surgery for congenital cleft of the palate, alveolar ridge, or lip\n* American Society of Anesthesiologists (ASA) physical status I or II\n* Written informed consent obtained from parents or legal guardians\n* Slovene-speaking family to ensure understanding and compliance\n* No contraindications to the use of study medications\n\nExclusion criteria:\n\n* Known allergy or hypersensitivity to ketamine, nalbuphine, or dexmedetomidine\n* ASA physical status greater than II\n* Significant neurological, psychiatric, or respiratory disorder\n* Active or recent upper respiratory tract infection\n* Refusal of parental or guardian consent\n* Developmental disorder affecting communication or cooperation","ALL","6 Months","3 Years",{"count":104,"type":105},60,"ESTIMATED","INTERVENTIONAL",[108],"NA","This prospective, randomized study is designed to compare the efficacy and safety of three sedative-analgesic agents-intramuscular ketamine, intranasal nalbuphine, and intranasal dexmedetomidine-for procedural sedation in children undergoing suture removal following cleft palate, alveolar ridge, or lip surgery. The study will include 60 children aged 6 months to 3 years, randomly assigned to one of three intervention groups.\n\nThe primary objectives are to compare time to achieve adequate sedation (Modified Ramsay Sedation Scale 2-3), surgeon-rated ease of surgical procedure, and time to discharge readiness (Modified Aldrete Score ≥9). Secondary outcomes include baseline child behavior, response to drug administration, depth of sedation, response to separation from parents, and parental satisfaction, as well as monitoring of perioperative complications and vital signs.\n\nAll study medications are approved and commonly used in pediatric anesthesia. The trial will be conducted using non-invasive monitoring, with intravenous access established only in case of emergency interventions. Findings from this study are expected to provide evidence to optimize pediatric sedation protocols for minor surgical procedures.",[111,112,113],"Orofacial Clefts","Cleft Lip and Palate","Alveolar Ridge Defect",[115,116,117,43,36,118,119,120],"pediatric sedation","Cleft surgery","Ketamine","Intranasal sedation","Intramuscular injection","Sedation in children","2026-01-05",{"date":123,"type":124},"2026-01-14","ACTUAL",{"date":126,"type":124},"2025-09-01",{"date":128,"type":105},"2029-01",{"name":5,"class":6},1]