[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04669457":3,"trial-entities:NCT04669457":115,"trial-summary:NCT04669457":118},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":41,"secondary_outcomes":52,"sex":81,"minimum_age":82,"maximum_age":83,"healthy_volunteers":84,"eligibility_criteria":85,"std_ages":96,"locations":98,"central_contacts":108,"overall_officials":109,"references":113,"see_also_links":114},"NCT04669457","H00021788","Pediatric Delirium","Prevention of Emergence Delirium in Pediatric Ambulatory Surgery: Single Blinded Randomized Control Study Comparing Intra-nasal Dexmedetomidine With Oral Midazolam.","ENROLLING_BY_INVITATION","2027-04-05","2026-07","2026-07-15","2021-04-27","University of Massachusetts, Worcester","OTHER",false,"Preventing emergent delirium in pediatric ambulatory surgery through preoperative use of intra-nasal Dexmedetomidine and oral Midazolam.","Pediatric ambulatory patients will randomly be allocated to one of two groups. Group A which will receive Dexmedetomidine intra-nasally at a dose of 1 mcg\u002Fkg, approximately 15-25 minutes before entering the operating room or Group B which will receive Midazolam orally at a dose of 0.5 mg\u002Fkg (with a maximum dose of 20 mg), approximately 10-15 minutes before entering the operating room. Each subject will receive a Drug Acceptance scale, and Parental Separation Anxiety Scale (PSAS) mask Acceptance Scale to identify the differences in markers associated with pediatric delirium. End tidal Sevoflurane value during the surgery and at the time when patient leaves the OR, amount and dose of oral\u002Frectal acetaminophen given in PACU, child's behavior for 48 hours post-operatively, and documented intake of oral analgesics will be collected to identify the reduced need for post-operative analgesia and behaviors associated with extended pediatric delirium.",[6],[],"INTERVENTIONAL","PREVENTION",[23],"PHASE4",{"count":25,"type":26},60,"ESTIMATED",[28,35],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Intra-nasal Dexmedetomidine","Subjects will receive Dexmedetomidine intra-nasally in the preoperative area. It will be administered at a dose of 1 mcg\u002Fkg, approximately 15-25 minutes before entering the operating room.",[30],[34],"Precedex",{"type":29,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Oral Midazolam","Subjects will receive Midazolam orally in the preoperative area. It will be administered at a dose of 0.5 mg\u002Fkg (with a maximum dose of 20 mg), approximately 10-15 minutes before entering the operating room.",[36],[40],"Midazolam",[42,46,49],{"measure":43,"description":44,"timeFrame":45},"Time to onset of pediatric delirium","Time from when the patient is woken from anesthesia to the onset of delirium.","Zero minutes to 48 hours",{"measure":47,"description":48,"timeFrame":45},"Time to offset of pediatric delirium","Time from onset of delirium to the offset of delirium.",{"measure":50,"description":51,"timeFrame":45},"Duration of pediatric delirium","Total time patient experiences delirium",[53,57,61,65,69,73,77],{"measure":54,"description":55,"timeFrame":56},"Drug Acceptance","The willingness of the subject to take the drug was assessed in the pre-operative area","10-25 minutes prior to surgery",{"measure":58,"description":59,"timeFrame":60},"Parental Separation Anxiety Scale (PSAS)","Anxiety score was determined when the child was separated from the parents according to four levels.","0-48 hours",{"measure":62,"description":63,"timeFrame":64},"Mask Acceptance Scale","The child's acceptance of the mask by the anesthesiologist was rated as follows.","1-10 minutes prior to surgery",{"measure":66,"description":67,"timeFrame":68},"End tidal Sevoflurane value","During the surgery and at the time when patient leaves the OR End tidal Sevoflurane value will be documented.","0-12 hours",{"measure":70,"description":71,"timeFrame":72},"Rescue analgesia in PACU","The amount and dose of oral\u002Frectal acetaminophen given in PACU was recorded.","0-6 hours post surgery",{"measure":74,"description":75,"timeFrame":76},"Home Behavior Analysis","The child's parents were given a diary to document their behavior for 48 hours post-operatively at home.","12-48 hours",{"measure":78,"description":79,"timeFrame":80},"Oral analgesic use","Document intake of oral analgesics like acetaminophen or ibuprofen","Two days post-operative","ALL","3 Months","9 Years",true,{"inclusion":86,"exclusion":90,"raw_text":95},[87,88,89],"Subjects age 3 months to 9 years","Scheduled to undergo a myringotomy","American Society of Anesthesiologists (ASA) classification of I - II.",[91,92,93,94],"Subjects with unrepaired cardiac defects, including cyanotic congenital heart disease.","Anyone age 10 years or older.","Anyone with an ASA classification of III or higher.","Non-English language speaker for whom short form consent is not available.","Inclusion Criteria:\n\n* Subjects age 3 months to 9 years\n* Scheduled to undergo a myringotomy\n* American Society of Anesthesiologists (ASA) classification of I - II.\n\nExclusion Criteria:\n\n* Subjects with unrepaired cardiac defects, including cyanotic congenital heart disease.\n* Anyone age 10 years or older.\n* Anyone with an ASA classification of III or higher.\n* Non-English language speaker for whom short form consent is not available.",[97],"CHILD",[99],{"facility":100,"city":101,"state":102,"zip":103,"country":104,"geoPoint":105},"University of Massachusetts Medical School","Worcester","Massachusetts","01655","United States",{"lat":106,"lon":107},42.26259,-71.80229,[],[110],{"name":111,"affiliation":13,"role":112},"R. Ian Richmond, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":116,"biomarkers":117},[6],[],{"nct_id":4,"found":84,"summary":119,"prompt_version":129},{"design":120,"status":121,"heading":122,"summary":123,"follow_up":124,"word_count":125,"commitments":126,"compensation":127,"drugs_mentioned":128},"This is an interventional study where 60 participants will be randomly assigned to one of two groups to receive either intra-nasal Dexmedetomidine or oral Midazolam before surgery.","completed","Preventing Delirium in Children Undergoing Surgery","This study is looking at ways to prevent pediatric delirium (a state of confusion and disorientation after surgery) in children aged 3 months to 9 years who are having a common ear surgery called a myringotomy. Researchers are comparing two different medications given before surgery: intra-nasal Dexmedetomidine and oral Midazolam. The goal is to see which medication is better at reducing how often children experience delirium, how long it lasts, and when it starts and stops. To join, your child must be between 3 months and 9 years old and scheduled for a myringotomy, with a healthy medical status (ASA classification I-II). The study's status is currently unclear, but it plans to enroll 60 children.","Participants will be followed for up to 48 hours after surgery to assess for pediatric delirium.",115,"Your child will receive one of the study medications before surgery and their behavior will be observed for up to 48 hours afterward.","Not stated in the trial record.",[30,36],"v2"]