[{"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":30,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":30,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":30,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":30,"overallStatus":45,"whyStopped":30,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"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",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":82,"type":83},96,"ESTIMATED","INTERVENTIONAL",[86],"NA","This study aims to compare the efficacy of using oral Melatonin versus nebulized Dexmedetomidine in limitation of emergence agitation in children undergoing adenotonsillectomy.",[89,90,91,92,93],"Oral Melatonin","Nebulized Dexmedetomidine","Emergence Agitation","Children","Adenotonsillectomy","2026-01-07",{"date":96,"type":97},"2026-01-16","ACTUAL",{"date":99,"type":97},"2025-07-01",{"date":101,"type":83},"2027-07-01",{"name":5,"class":6},1]