[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643719":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":19,"centralContacts":30,"locations":36,"responsibleParty":52,"collaborators":19,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":19,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":85,"whyStopped":19,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"TC Erciyes University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Pre-emptive Local Anesthesia","EXPERIMENTAL","Children randomized to this group will receive pre-emptive local anesthesia administered by the pediatric dentist before the dental procedure under general anesthesia.",[13,14],"Procedure: Pre-emptive Local Anesthesia","Drug: Articaine Hydrochloride With Epinephrine",{"label":16,"type":17,"description":18,"interventionNames":19},"No Local Anesthesia","NO_INTERVENTION","Children randomized to this group will undergo dental treatment under general anesthesia without routine pre-emptive local anesthesia. Rescue analgesia or additional local anesthesia may be administered if clinically required and will be recorded.",null,[21,25],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":19},"PROCEDURE","Pre-emptive local anesthesia will be administered by the pediatric dentist before the dental procedure according to the planned treatment area. The local anesthetic agent, total volume, total dose, dose per kilogram, and injection sites will be recorded.",[9],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":19},"DRUG","Articaine Hydrochloride With Epinephrine","Articaine hydrochloride with epinephrine will be administered as local anesthesia by the pediatric dentist before the dental procedure in participants randomized to the pre-emptive local anesthesia group. The total volume, total dose, dose per kilogram, and injection sites will be recorded.",[9],[31],{"name":32,"role":33,"phone":34,"phoneExt":19,"email":35},"Seher Orbay Yaşlı, Assistant Professor of Anesthe","CONTACT","+905052401933","sehersin81@hotmail.com",[37],{"facility":38,"status":19,"city":39,"state":39,"zip":40,"country":41,"countryCode":19,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Erciyes University Faculty of Dentistry","Kayseri","38039","Turkey (Türkiye)",{"type":43,"coordinates":44},"Point",[45,46],35.48528,38.73222,{"lat":46,"lon":45},[49],{"name":50,"role":33,"phone":51,"phoneExt":19,"email":35},"SEHER Orbay Yaşlı","05052401933",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"SPONSOR_INVESTIGATOR","seher orbay yasli","Assistant Professor of Anesthesiology and Reanimation","100643719","pre-emptive-local-anesthesia-and-emergence-behavior-after-pediatric-dental-general-anesthesia-100643719",false,"NCT07604337","Pre-emptive Local Anesthesia and Emergence Behavior After Pediatric Dental General Anesthesia","Effects of Pre-emptive Local Anesthesia on Emergence Behavior and Early Recovery Quality After Ambulatory Pediatric Dental General Anesthesia: A Parallel-Group Randomized Controlled Trial","PEDLA-QOR","Inclusion Criteria:\n\n* Children aged 7 to 12 years\n* ASA physical status I or II\n* Scheduled for ambulatory dental treatment under general anesthesia\n* Ability to understand and respond to age-appropriate pain and recovery assessment tools\n* Written informed consent obtained from a parent or legal guardian\n* Child assent obtained when appropriate\n\nExclusion Criteria:\n\n* Known allergy or contraindication to local anesthetic agents\n* Developmental delay or cognitive impairment preventing assessment\n* Autism spectrum disorder or severe behavioral disorder\n* Neurological disease affecting behavior or consciousness\n* Chronic analgesic or sedative medication use\n* Severe hepatic, renal, cardiac, or respiratory disease\n* Emergency dental procedure\n* Need for postoperative hospital admission\n* Inability to complete postoperative assessment tools","ALL","7 Years","12 Years",{"count":68,"type":69},80,"ESTIMATED","INTERVENTIONAL",[72],"NA","This study will evaluate whether pre-emptive local anesthesia improves early recovery after ambulatory pediatric dental general anesthesia. Children aged 7-12 years scheduled for dental treatment under general anesthesia will be randomly assigned to receive either pre-emptive local anesthesia or no local anesthesia. Emergence delirium, pain, sedation level, and recovery quality will be assessed during the early postoperative period. The primary outcome will be the longitudinal Pediatric Anesthesia Emergence Delirium Scale score during the first 30 minutes in the post-anesthesia care unit.",[75,76,77],"Emergence Delirium","Pediatric Dental General Anesthesia","Postoperative Recovery",[79,80,81,82,83,84],"Pre-emptive local anesthesia","Pediatric anesthesia","Dental anesthesia","Emergence behavior","QoR-15 Pictorial","Ambulatory surgery","NOT_YET_RECRUITING","2026-06-05",{"date":88,"type":89},"2026-06-09","ACTUAL",{"date":91,"type":69},"2026-06",{"date":93,"type":69},"2026-12",{"name":54,"class":6},1]