[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07576985":3,"trial-entities:NCT07576985":72,"trial-summary:NCT07576985":75},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":28,"primary_purpose":16,"phases":29,"enrollment_info":30,"interventions":33,"primary_outcomes":39,"secondary_outcomes":44,"sex":48,"minimum_age":16,"maximum_age":49,"healthy_volunteers":14,"eligibility_criteria":50,"std_ages":57,"locations":59,"central_contacts":68,"overall_officials":69,"references":70,"see_also_links":71},"NCT07576985","STUDY00000739","Evaluating the Efficacy of Intravenous Acetaminophen (IV Tylenol) in Reducing Pain and Agitation in Pediatric Patients Undergoing Elective Tonsillectomy and\u002For Adenoidectomy","ENROLLING_BY_INVITATION","2026-08-01","2026-05","2026-05-08","2025-04-21","MetroHealth Medical Center","OTHER",false,"MetroHealth's main campus administers IV Tylenol as part of its pain management protocol for elective tonsillectomy\u002Fadenoidectomy, whereas Parma campus does not. Comparing these practices provides an opportunity to evaluate the benefits of IV Tylenol for pain, agitation, and associated secondary outcomes in this population. The pain\u002Fagitation would be assessed with a validated tool PAED and FLACC",null,[18,19],"Tonsillectomy","Adenoidectomy",[21,22,23,24,25,26,27],"acetaminophen","pain","pediatric","intravenous","per os","flacc","paed","OBSERVATIONAL",[],{"count":31,"type":32},20,"ESTIMATED",[34],{"type":13,"name":35,"description":35,"armGroupLabels":36},"No Intervention: Observational Cohort",[37,38],"Acetaminophen per os","Intravenous Acetaminophen",[40],{"measure":41,"description":42,"timeFrame":43},"Pain Assessment","Evaluate the impact of IV Acetaminophen on pain at emergence and in the Post-Anesthesia Care Unit (PACU) using a validated pediatric assessment tool, FLACC (Face, Legs, Activity, Cry, Consolable) Behavior Pain Assessment Tool.","* \"Baseline\" * \"Perioperative\u002FPeriprocedural\"",[45],{"measure":46,"description":47,"timeFrame":43},"Agitation Assessment","Evaluate the impact of IV Tylenol on Agitation scores at emergence and in the Post-Anesthesia Care Unit (PACU) using a validated pediatric assessment tool, Pediatric Anesthesia Emergence Delirium (PAED) scale.","ALL","8 Years",{"inclusion":51,"exclusion":54,"raw_text":56},[52,53],"Subjects pediatric patients aged ≤7 years, observed by study team who will complete the scales","Undergoing elective tonsillectomy and adenoidectomy.",[55],"Pre-existing neurological or developmental disorders impacting pain\u002Fagitation scores","Inclusion Criteria:\n\n* Subjects pediatric patients aged ≤7 years, observed by study team who will complete the scales\n* Undergoing elective tonsillectomy and adenoidectomy.\n\nExclusion Criteria:\n\n* Pre-existing neurological or developmental disorders impacting pain\u002Fagitation scores",[58],"CHILD",[60],{"facility":12,"city":61,"state":62,"zip":63,"country":64,"geoPoint":65},"Cleveland","Ohio","44109-1997","United States",{"lat":66,"lon":67},41.4995,-81.69541,[],[],[],[],{"nct_id":4,"conditions":73,"biomarkers":74},[19,18],[],{"nct_id":4,"found":14,"summary":16,"prompt_version":16}]