[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619522":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":30,"centralContacts":37,"locations":43,"responsibleParty":68,"collaborators":30,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":30,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":30,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":30,"overallStatus":45,"whyStopped":30,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Tanta University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Group C (Control Group)","ACTIVE_COMPARATOR","Participants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.5 mg\u002Fkg of midazolam dissolved in Apple Juice.",[13],"Drug: Normal saline",{"label":15,"type":16,"description":17,"interventionNames":18},"Melatonin Group","EXPERIMENTAL","Participants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.2 mg\u002Fkg of oral melatonin syrup.",[19],"Drug: Oral melatonin syrup",{"label":21,"type":16,"description":22,"interventionNames":23},"Dexmedetomidine Group","Participants will receive placebo syrup (Apple Juice) and 2 µ\u002Fkg nebulized dexmedetomidine prepared in 0.9% normal saline to a final volume of 3ml.",[24],"Drug: Nebulized dexmedetomidine",[26,31,34],{"type":27,"name":28,"description":11,"armGroupLabels":29,"otherNames":30},"DRUG","Normal saline",[9],null,{"type":27,"name":32,"description":17,"armGroupLabels":33,"otherNames":30},"Oral melatonin syrup",[15],{"type":27,"name":35,"description":22,"armGroupLabels":36,"otherNames":30},"Nebulized dexmedetomidine",[21],[38],{"name":39,"role":40,"phone":41,"phoneExt":30,"email":42},"Amany A Eid, MSc","CONTACT","00201012301802","amany.kamel@med.tanta.edu.eg",[44],{"facility":5,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Tanta","El-Gharbia","31527","Egypt","EG",{"type":52,"coordinates":53},"Point",[54,55],31.00192,30.78847,{"lat":55,"lon":54},[58,59,62,64,66],{"name":39,"role":40,"phone":41,"phoneExt":30,"email":42},{"name":60,"role":61,"phone":30,"phoneExt":30,"email":30},"Nagat S Elshamaa, MD","SUB_INVESTIGATOR",{"name":63,"role":61,"phone":30,"phoneExt":30,"email":30},"Shaimaa F Mostafa, MD",{"name":65,"role":61,"phone":30,"phoneExt":30,"email":30},"Mona R Elghamry, MD",{"name":67,"role":61,"phone":30,"phoneExt":30,"email":30},"Osama M Rehab, MD",{"type":69,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Amany Abd Elsamd Kamel Eid","Assistant Lecturer of Anesthesia, Surgical Intensive Care and Pain Medicine, Tanta University, Tanta, Egypt.","100619522","oral-melatonin-versus-nebulized-dexmedetomidine-on-emergence-agitation-in-children-undergoing-adenotonsillectomy-100619522",false,"NCT07345715","Oral Melatonin Versus Nebulized Dexmedetomidine on Emergence Agitation in Children Undergoing Adenotonsillectomy","Comparison Between Oral Melatonin Versus Nebulized Dexmedetomidine on Emergence Agitation in Children Undergoing Adenotonsillectomy: A Prospective, Randomized Controlled Trial","Inclusion Criteria:\n\n* Children aged between 3 and 7 years.\n* Both sexes.\n* Classified as American Society of Anesthesiologists (ASA) physical status I or II according to the American Society of Anesthesiologists.\n* Scheduled for elective adenotonsillectomy under general anesthesia.\n\nExclusion Criteria:\n\n* Parental refusal to participate in the study.\n* Known allergy or hypersensitivity to dexmedetomidine, melatonin or midazolam.\n* Presence of developmental delay.\n* Central nervous system disorders.\n* Intellectual disability (formerly termed mental retardation).\n* Neurological or psychiatric conditions associated with anxiety or agitation (e.g., cerebral palsy, epilepsy, separation anxiety disorder, attention-deficit\u002Fhyperactivity disorder).\n* Current or recent treatment with anticonvulsants or sedative medications","ALL","3 Years","7 Years",{"count":83,"type":84},96,"ESTIMATED","INTERVENTIONAL",[87],"NA","This study aims to compare the efficacy of using oral Melatonin versus nebulized Dexmedetomidine in limitation of emergence agitation in children undergoing adenotonsillectomy.",[90,91,92,93,94],"Oral Melatonin","Nebulized Dexmedetomidine","Emergence Agitation","Children","Adenotonsillectomy","2026-01-07",{"date":97,"type":98},"2026-01-16","ACTUAL",{"date":100,"type":98},"2025-07-01",{"date":102,"type":84},"2027-07-01",{"name":5,"class":6},1]