[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637160":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":40,"centralContacts":44,"locations":50,"responsibleParty":67,"collaborators":27,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":27,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":93,"whyStopped":27,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Montefiore Medical Center","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral Drug + IV Placebo","ACTIVE_COMPARATOR","Oral Acetaminophen 1000mg + IV placebo\n\nOral Acetaminophen 1000mg\n\nNo additional analgesics will be administered prior to two hours unless clinically indicated. Rescue analgesia may be administered at any time at the discretion of the treating clinician.",[13,14],"Drug: Acetaminophen 1000mg PO","Other: IV Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Intravenous Drug + Oral Placebo","Intravenous Acetaminophen + PO placebo\n\nIV Acetaminophen 1000mg\n\nNo additional analgesics will be administered prior to two hours unless clinically indicated. Rescue analgesia may be administered at any time at the discretion of the treating clinician.",[19,20],"Drug: IV Acetaminophen 1000mg","Other: PO Placebo",[22,28,32,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Acetaminophen 1000mg PO","Oral Acetaminophen 1000mg",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"IV Acetaminophen 1000mg","Intravenous Acetaminophen 1000mg",[16],{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"IV Placebo","IV placebo administration",[9],{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":27},"PO Placebo","Oral placebo administration",[16],[41],{"name":42,"affiliation":5,"role":43},"Eddie M Irizarry, MD","PRINCIPAL_INVESTIGATOR",[45],{"name":46,"role":47,"phone":48,"phoneExt":27,"email":49},"Mustfa Manzur, MD MPH MS","CONTACT","718-920-6674","mmanzur@montefiore.org",[51],{"facility":5,"status":27,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"The Bronx","New York","10467","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-73.86641,40.84985,{"lat":61,"lon":60},[64,66],{"name":46,"role":47,"phone":65,"phoneExt":27,"email":49},"718-920-6626",{"name":42,"role":43,"phone":27,"phoneExt":27,"email":27},{"type":68,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100637160","phase-4-comparing-pain-improvement-for-intravenous-versus-oral-acetaminophen-in-acute-pelvic-pain-100637160",false,"NCT07595302","Comparing Pain Improvement for Intravenous Versus Oral Acetaminophen in Acute Pelvic Pain","Comparing Pain Improvement for Intravenous Versus Oral Acetaminophen in Acute Pelvic Pain: A Randomized, Double-Blind, Double-Dummy Controlled Trial (PIVOTAL Trial)","PIVOTAL","Inclusion Criteria:\n\n* Female sex at birth\n* Presentation to the Emergency Department (ED) with pelvic pain\n* Baseline numeric pain score (NRS) ≥4\n* Ability to provide informed consent in English or Spanish\n\nExclusion Criteria:\n\n* Receipt of any analgesic medication within 2 hours or acetaminophen within 6 hours\n* Known allergy or intolerance to acetaminophen","FEMALE","16 Years","50 Years",{"count":81,"type":82},140,"ESTIMATED","INTERVENTIONAL",[85],"PHASE4","The investigator team proposes a randomized, double-blind, double-dummy comparative effectiveness trial conducted in two urban emergency departments (EDs) in the Bronx, New York. This study is designed to determine the relative efficacy of IV acetaminophen compared to PO acetaminophen in treating pelvic pain. This design focuses on the early onset of action and short-term efficacy, which may better capture potential differences between IV and PO acetaminophen in the acute ED setting.",[88],"Pelvic Pain",[90,91,92],"pregnancy","acetaminophen","randomized controlled trial","NOT_YET_RECRUITING","2026-05-18",{"date":96,"type":97},"2026-05-20","ACTUAL",{"date":99,"type":82},"2026-07-30",{"date":101,"type":82},"2027-06-30",{"name":5,"class":6},1]