[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491626":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":45,"locations":52,"responsibleParty":69,"collaborators":31,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":31,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":55,"whyStopped":31,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University Hospital, Montpellier","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Premedication Group (Midazolam)","EXPERIMENTAL","Midazolam (0,5 mg\u002Fkg; max 10 mg), oral administration, 45 minutes prior entering in the operating room",[13],"Drug: Midazolam",{"label":15,"type":10,"description":16,"interventionNames":17},"Premedication Group (Dexmedetomidine)","Dexmedetomidine (2 µg\u002Fkg), oral administration, 45 minutes prior entering in the operating room",[18],"Drug: Dexmedetomidine",{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo Group","PLACEBO_COMPARATOR","grenadine syrup (3 mL), oral administration, 45 minutes prior entering in the operating room",[24],"Drug: Placebo",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Midazolam","45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Midazolam , by a blinded nurse.",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Dexmedetomidine","45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Dexmedetomidine , by a blinded nurse.",[15],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Placebo","45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Grenadine Syrup, by a blinded nurse.",[20],[41],{"name":42,"affiliation":43,"role":44},"Christophe DADURE, PHD","Hospital of Montpellier","STUDY_DIRECTOR",[46],{"name":47,"role":48,"phone":49,"phoneExt":50,"email":51},"Sophie BRINGUIER, PHD","CONTACT","0467338661","+33","s-bringuierbranchereau@chu-montpellier.fr",[53],{"facility":54,"status":55,"city":56,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Uhmontpellier","RECRUITING","Montpellier","34295","France","FR",{"type":61,"coordinates":62},"Point",[63,64],3.87635,43.61093,{"lat":64,"lon":63},[67],{"name":68,"role":48,"phone":49,"phoneExt":50,"email":51},"Sophie BRINGUIER, PHARM D, phD",{"type":70,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100491626","phase-3-effect-of-sedative-and-anxiolytic-premedication-on-children-experience-after-general-anesthesia-100491626",false,"NCT05681572","Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia","\" Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia \" The pediaPREM Study.","pediaPREM","Inclusion Criteria:\n\n* Subject over 7 and under 18 years of age\n* Subjects who are scheduled for surgery\n* Subject who will be under general anesthesia\n* Subject able to complete a self-questionnaire in French\n\nExclusion Criteria:\n\n* Subject who has already participated in the pediaPREM study\n* Subject with a treated anxiety disorder\n* Subject with cognitive disorders\n* Subject suffering from chronic pain (outside the operated area)\n* Subject with ADD (Attention Deficit Disorder) with or without hyperactivity, with or without treatment\n* Subject suffering from mental retardation\n* Subjects receiving psychotropic treatment\n* Subject whose intervention could reduce the ability to complete a self-questionnaire (neurosurgery etc.)\n* Subject with a contra-indication to midazolam and its excipients\n* Subject with a contra-indication to dexmedetomidine and its excipients\n* Subjects who need to receive intravenous alpha agonist in perioperative\n* Subjects requiring emergency intervention\n* Subjects requiring preoperative hypnosis\n* Subject who needs general anesthesia for diagnostic purposes (biopsy, etc...)\n* Subject having had a surgical intervention in the month preceding the inclusion.\n* Subject who will have an iterative surgical intervention within 15 days (removal of material, burns etc...)\n* Subjects who are scheduled for surgery as part of oncology management\n* Pregnant or breastfeeding woman\n* Subject whose two parents have not signed a written informed consent\n* Subjects who are not affiliated with or benefiting from a social security plan","ALL","7 Years","18 Years",{"count":83,"type":84},1000,"ESTIMATED","INTERVENTIONAL",[87],"PHASE3","Children undergoing general anesthesia for surgery commonly need sedative and anxiolytic premedication but little clinical evidence supports is benefit for children older than 7 years old.\n\nThe aim of this prospective randomized clinical trial is to assess the impact of pharmacologic premedication on perioperative children experience.",[90],"Anesthesia",[92,93,94,95,96],"children premedication","anesthesia","children perioperative experience","anxiety","sedation","2026-07-16",{"date":99,"type":100},"2026-07-17","ACTUAL",{"date":102,"type":100},"2023-04-18",{"date":104,"type":84},"2027-10-18",{"name":5,"class":6},1]