[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100480845":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":42,"responsibleParty":64,"collaborators":67,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":25,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Melatonin","EXPERIMENTAL","Participants receive melatonin solution for injection 1 mg\u002FmL in a dosage of 0.15 mg\u002Fkg body weight as a single intravenous injection approximately 30 minutes before end of surgical procedure.",[13],"Drug: Melatonin",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants receive isotonic sodium chloride (9mg\u002FmL) intravenously once approximately 30 minutes before end of surgical procedure in a volume equivalent to the melatonin group for the same weight.",[19],"Drug: Isotonic sodium chloride solution",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Melatonin for injection 1 mg\u002FmL",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Isotonic sodium chloride solution","Sodium chloride 0.9 % for injection",[15],[31],"Normal saline",[33],{"name":34,"affiliation":5,"role":35},"Arash L Afshari, MD, PhD","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":25,"email":41},"Anne Louise B Garioud, MD","CONTACT","+4535456243","anne.louise.de.barros.garioud@regionh.dk",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Department of Anesthesiology, Juliane Marie Center, Rigshospitalet","RECRUITING","Copenhagen","Capital Region","2100","Denmark","DK",{"type":52,"coordinates":53},"Point",[54,55],12.56553,55.67594,{"lat":55,"lon":54},[58,60],{"name":38,"role":39,"phone":59,"phoneExt":25,"email":41},"0045 35456243",{"name":61,"role":39,"phone":62,"phoneExt":25,"email":63},"Arash Afshari, MD, PhD","0045 35458749","arash.afshari@regionh.dk",{"type":35,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Arash Afshari","Head of Research, Associated Professor",[68,70,72],{"name":69,"class":6},"Sygehus Lillebaelt",{"name":71,"class":6},"University of Copenhagen",{"name":73,"class":6},"Copenhagen Trial Unit, Center for Clinical Intervention Research","100480845","phase-3-melatonin-for-prevention-of-postoperative-agitation-and-emergence-delirium-in-children-100480845",false,"NCT05541276","MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children","MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children. The MELA-PAED Trial: a Randomized, Double-blind, Placebo-controlled Trial.","MELA-PAED","Inclusion Criteria:\n\n* Patients aged 1-6 years\n* Elective surgical procedure of en axpected duration of at least 30 minutes in general anesthesia maintained with sevoflurane\n\nExclusion Criteria:\n\n* Any known allergy or contraindication to study treatment or excipåients\n* Current daily medication with melatonin","ALL","1 Year","6 Years",{"count":86,"type":87},400,"ESTIMATED","INTERVENTIONAL",[90],"PHASE3","Postoperative agitation and emergence delirium describe a spectrum of symptoms of early postoperative negative behavior, in which the child experiences a variety of behavioral disturbances including crying, thrashing, and disorientation during early awakening from anaesthesia. The symptoms are common with a reported incidence of approximately 25%. Some clinical trials have studied the effect of prophylactic oral melatonin for reducing the risk of emergence agitation in children, some finding a considerable dose-response effect. Melatonin has a low bio-availability of approximately 15 %. The safety of exogenous melatonin for pediatric patients has been studied with no apparent serious adverse effects, even at repeated short-term use of high doses of intravenous melatonin. The aim of this clinical trial is to investigate the prophylactic effects and safety of intravenous melatonin administered intraoperatively for prevention of postopreative agitation and emergence delirium in children after an elective surgical procedure. The study is designed as a randomised, double-blind, placebo-controlled clinical trial.",[93],"Emergence Delirium",[95,9,96,97,98,99],"Anesthesia","Sevoflurane","Postoperative Pain","Child","PONV","2025-01-22",{"date":102,"type":103},"2025-01-24","ACTUAL",{"date":105,"type":103},"2025-01-21",{"date":107,"type":87},"2027-01-01",{"name":5,"class":6},1]