[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621801":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":29,"responsibleParty":48,"collaborators":11,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":11,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":11,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":32,"whyStopped":11,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Benha University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group M (Melatonin Group)","ACTIVE_COMPARATOR",null,[13],"Drug: Melatonin",{"label":15,"type":16,"description":11,"interventionNames":17},"Group P (Placebo Group)","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Melatonin","Participants will receive Oral melatonin at a dose of 0.5 mg\u002Fkg (maximum 20 mg) administered 30 minutes before induction of anesthesia. Dose chosen based on prior pediatric studies and safety data. The tablet will be crushed and mixed with a small amount of water or juice to facilitate administration,",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Placebo","Participants will receive an identical placebo tablet administered 30 minutes before induction of anesthesia.\n\nThe tablet will be crushed and mixed with a small amount of water or juice to facilitate administration,",[15],[30],{"facility":31,"status":32,"city":33,"state":11,"zip":11,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Benha University Hospital","RECRUITING","Banhā","Egypt","EG",{"type":37,"coordinates":38},"Point",[39,40],31.1842,30.45977,{"lat":40,"lon":39},[43],{"name":44,"role":45,"phone":46,"phoneExt":11,"email":47},"Taghreed Sakr, MD degree of anesthesia","CONTACT","00201112723187","taghreed.sakr@fmed.bu.edu.eg",{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Taghreed Elshahat Sakr","lecturer of anesthesia and icu","100621801","melatonin-for-post-tonsillectomy-emergence-agitation-in-pediatric-100621801",false,"NCT07375342","Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric","Effect of Preoperative Oral Melatonin on Emergence Agitation Following Pediatric Tonsillectomy: a Randomized Controlled Trial","Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status I or II.\n* Parent\u002Flegal guardian provides written informed consent\n\nExclusion Criteria:\n\n* • Known allergy or contraindication to melatonin.\n\n  * Pre-existing neurological or psychiatric disorders (e.g., epilepsy, autism, ADHD).\n  * Children receiving any sedative or psychoactive medication within 48 hours of surgery.\n  * Emergency surgery or any procedure other than tonsillectomy\u002Fadenoidectomy.\n  * Children with known sleep disorders or those taking melatonin supplements.\n  * Developmental delay, neurologic disorders, sleep disorders, or known obstructive sleep apnea requiring ICU postoperatively.\n  * Hepatic or renal dysfunction (ALT\u002FAST \\>2×ULN, Cr \\>1.5 mg\u002FdL)","ALL","4 Years","10 Years",{"count":63,"type":64},120,"ESTIMATED","INTERVENTIONAL",[67],"NA","The goal of this clinical trial is to learn if melatonin can decrease emergence agitation in pediatric post tonsillectomy. The main questions it aims to answer are:\n\nDoes melatonin decrease emergence agitation in pediatric post tonsillectomy? What medical problems do participants have when taking melatonin? Researchers will compare melatonin to a placebo (a look-alike substance that contains no drug) to see if melatonin works todecrease emergence agitation in pediatric post tonsillectomy\n\nParticipants will receive Oral melatonin at a dose of 0.5 mg\u002Fkg (maximum 20 mg) administered 30 minutes before induction of anesthesia. Dose chosen based on prior pediatric studies and safety data.",[70],"Post Tonsillectomy Emergence Agitation",[72,73,74],"agitation","tonsillectomy","pediatric","2026-07-16",{"date":77,"type":78},"2026-07-17","ACTUAL",{"date":80,"type":78},"2025-12-10",{"date":82,"type":64},"2026-08-01",{"name":5,"class":6},1]