[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574268":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":38,"centralContacts":43,"locations":49,"responsibleParty":66,"collaborators":68,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":47,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":47,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":52,"whyStopped":47,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Boston University","OTHER",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Alternating analgesics","EXPERIMENTAL","Participants randomized into this arm will be given alternating Ibuprofen and Acetaminophen every 6 hours, alternating the two medications every 3 hours: first dose ibuprofen, three hours later acetaminophen for 24 hours.",[13,14],"Drug: Ibuprofen","Drug: Acetominophen",{"label":16,"type":10,"description":17,"interventionNames":18},"Simultaneous post-operative analgesics","Participants randomized into this arm will be given simultaneous Ibuprofen and Acetaminophen every 6 hours for 24 hours.",[13,14],{"label":20,"type":21,"description":22,"interventionNames":23},"Control Standard of Care","ACTIVE_COMPARATOR","Participants randomized into this arm will be given Ibuprofen every 6 hours for 24 hours.",[13],[25,32],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Ibuprofen","10 mg\u002Fkg\u002Fdose of ibuprofen will be given every 6 hours for 24 hours post surgery",[9,20,16],[31],"Motrin",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Acetominophen","15 mg\u002Fkg\u002Fdose of acetominophen will be given every 6 hours for 24 hours post surgery",[9,16],[37],"Tylenol",[39],{"name":40,"affiliation":41,"role":42},"Keri Discepolo, DDS MPH","BU Goldman School of Dental Medicine, Pediatrics","PRINCIPAL_INVESTIGATOR",[44],{"name":40,"role":45,"phone":46,"phoneExt":47,"email":48},"CONTACT","617-358-3446",null,"kdiscep@bu.edu",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Franciscan Children's Hospital","RECRUITING","Brighton","Massachusetts","02135","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-71.15644,42.3501,{"lat":62,"lon":61},[65],{"name":40,"role":45,"phone":46,"phoneExt":47,"email":48},{"type":67,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR",[69],{"name":70,"class":6},"Franciscan Hospital For Children, INC.","100574268","phase-4-management-of-postoperative-discomfort-in-young-children-following-dental-rehabilitation-under-general-anesthesia-100574268",false,"NCT06757075","Management of Postoperative Discomfort in Young Children Following Dental Rehabilitation Under General Anesthesia","A Comparison of Standard Dose of Ibuprofen Alone, Alternating, or Combined With Acetaminophen for the Management of Postoperative Discomfort in Young Children Following Dental Rehabilitation Under General Anesthesia","Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) I-II\n* Requiring Oral Rehabilitation under General Anesthesia\n* Possess legal guardians proficient in English\n* Not have a history of any adverse\u002Fallergic reaction to nonsteroidal anti-inflammatory drugs (NSAIDs) or Acetaminophen\n\nExclusion Criteria:\n\n* ASA III or IV\n* Asthma diagnosis\n* Contraindication to acetaminophen or ibuprofen","ALL","4 Years","6 Years",{"count":82,"type":83},75,"ESTIMATED","INTERVENTIONAL",[86],"PHASE4","The purpose of this study is to investigate the effectiveness of various oral analgesic regimens in minimizing post-operative pain and discomfort in young children following dental rehabilitation under general anesthesia (DRGA). In this randomized controlled trial, three analgesic regimens following DRGA in Franciscan Children's Hospital will be compared using both self-report and behavioral measures.\n\nThe analgesic therapies to be investigated are ibuprofen monotherapy, alternating ibuprofen and acetaminophen dual-therapy, and combined ibuprofen and acetaminophen dual-therapy. For the purposes of this study, combined therapy is defined as the simultaneous administration of acetaminophen and ibuprofen at regular intervals, whereas alternating therapy is defined as one analgesic (acetaminophen or ibuprofen) administered within a 3 hour interval of the other.",[89],"Pain, Postoperative",[91,92,33,27,93],"Dental rehabilitation under general anesthesia (DRGA)","Dental surgery patients 4-6 years","Pacing analgesics","2026-03-30",{"date":96,"type":97},"2026-04-02","ACTUAL",{"date":99,"type":97},"2025-04-16",{"date":101,"type":83},"2027-03",{"name":5,"class":6},1]