[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553687":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":44,"locations":50,"responsibleParty":86,"collaborators":89,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":31,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":31,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":53,"whyStopped":31,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Al-Azhar University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"1st group: melatonin 0.2 mg\u002Fkg group","ACTIVE_COMPARATOR","patients will receive oral melatonin at a dose of 0.2 mg\u002Fkg",[13],"Drug: melatonin (Circadin ®) 0.2 mg\u002Fkg",{"label":15,"type":10,"description":16,"interventionNames":17},"2nd group: M04 groupmelatonin 0.4 mg\u002Fkg group","patients will receive oral melatonin at a dose of 0.4 mg\u002Fkg",[18],"Drug: melatonin (Circadin ®) 0.4 mg\u002Fkg",{"label":20,"type":21,"description":22,"interventionNames":23},"3rd group: placebo group","PLACEBO_COMPARATOR","patients will receive oral placebo premedication",[24],"Drug: placebo group",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","melatonin (Circadin ®) 0.2 mg\u002Fkg","Patients will receive oral melatonin at a dose of 0.2 mg\u002Fkg as premedication in the morning of the surgery, 90 minutes before the induction of anesthesia, with a maximum dose of melatonin set at 10 mg.",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"melatonin (Circadin ®) 0.4 mg\u002Fkg","Patients will receive oral melatonin at a dose of 0.4 mg\u002Fkg as premedication in the morning of the surgery, 90 minutes before the induction of anesthesia, with a maximum dose of melatonin set at 10 mg.",[15],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"placebo group","Patients will receive oral placebo as premedication in the morning of the surgery, 90 minutes before the induction of anesthesia, with a maximum dose of melatonin set at 10 mg.",[20],[41],{"name":42,"affiliation":5,"role":43},"Neveen Kohaf, ph.d","PRINCIPAL_INVESTIGATOR",[45],{"name":46,"role":47,"phone":48,"phoneExt":31,"email":49},"Neveen Kohaf, Ph.D","CONTACT","01060383012","nevenabdo@azhar.edu.eg",[51,70],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Facualty of Pharmacy, Al Azhar University","RECRUITING","Cairo","Cairo Governorate","11765","Egypt","EG",{"type":60,"coordinates":61},"Point",[62,63],31.24967,30.06263,{"lat":63,"lon":62},[66,68],{"name":67,"role":47,"phone":48,"phoneExt":31,"email":49},"Neveen Kohaf",{"name":69,"role":43,"phone":31,"phoneExt":31,"email":31},"Haider Hamza, M.D",{"facility":71,"status":53,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Al-Ayen Univerisity","Madīnat Bābil","Babel","51015","Iraq","IQ",{"type":60,"coordinates":78},[79,80],44.41477,32.53991,{"lat":80,"lon":79},[83],{"name":69,"role":47,"phone":84,"phoneExt":31,"email":85},"+9647811593388","hussein.hussein@alayen.edu.iq",{"type":43,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Neveen Abd El Maksoad Kohaf","Lecturer of Clinical Pharmacy",[90],{"name":91,"class":6},"Al-Ayen Iraqi University","100553687","comparing-two-doses-of-oral-melatonin-as-premedication-in-children-undergoing-surgery-100553687",false,"NCT06489327","Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery","Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery: A Double-Blind Randomized Trial","Inclusion Criteria:\n\n* Patients of either sex\n* age from 4 to 14 years\n* Patients with American society Anesthesiologist physical status I and II\n* Patients undergoing elective surgeries\n\nExclusion Criteria:\n\n* ASA more than III\n* Drug allergy.\n* Gastrointestinal disorders.","ALL","4 Years","10 Years",{"count":103,"type":104},120,"ESTIMATED","INTERVENTIONAL",[107],"NA","Preoperative anxiety is a common issue in pediatric anesthesia. Children often experience anxiety and uneasiness due to uncertain outcomes. Surgery and anesthesia are among the most traumatic experiences for children, often considered anxiety-inducing medical treatments. Because they lack control over their environment and circumstances, children undergoing medical procedures typically experience significant unease or anxiety. Several studies have reported that 50%-80% of children experience preoperative anxiety.\n\nIn order to reduce kids anxiety intensity, several measures are utilized. These strategies are either pharmacological, psychological, or behavioural. Benzodiazepines are popular drugs that can reduce anxiety in children. The most used one in premedication is midazolam. It is a rapid-acting benzodiazepine that has a short elimination half-life. It has sedative, anxiolytic, hypnotic, and anterograde amnesic effects. Midazolam, on the other hand, might have a number of negative consequences, including paradoxical reactions, interactions with opioids, excessive sedation, disorientation, and reduced psychomotor performance.\n\nMelatonin enhances anti-nociceptive effects, most prominently through the modulation of MT1\u002FMT2 receptors in the brain and spinal cord. In addition, it has been demonstrated that melatonin can interact with additional receptors, including those in the GABAergic system, the nitric oxide (NO)arginine route, the N-Methyl-D-aspartate (NMDA) system, and the dopaminergic system, to produce anti-nociceptive and anti-allodynic effects.",[110],"Preoperative Anxiety",[112,113,114,115,116,117],"preoperative anxiety","general anesthesia","major surgery","oral melatonin","placebo","premedication","2026-01-04",{"date":120,"type":121},"2026-01-06","ACTUAL",{"date":123,"type":104},"2026-07-12",{"date":125,"type":104},"2026-12-15",{"name":5,"class":6},2]