[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636866":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":23,"centralContacts":39,"locations":50,"responsibleParty":66,"collaborators":23,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":23,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":23,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":96,"whyStopped":23,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University of Puerto Rico","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Intravenous Acetaminophen","EXPERIMENTAL","Participants randomized to this arm will receive acetaminophen 1 g administered intravenously approximately 30 minutes prior to surgical incision during orthognathic surgery under general anesthesia. A second dose will be administered near the end of the surgical procedure according to the medication half-life. Postoperative pain outcomes will be compared with the other study groups.",[13],"Drug: Acetaminophen",{"label":15,"type":10,"description":16,"interventionNames":17},"Intravenous Ibuprofen","Participants randomized to this arm will receive ibuprofen 600 mg administered intravenously approximately 30 minutes prior to surgical incision during orthognathic surgery under general anesthesia. A second dose will be administered near the end of the procedure according to the medication half-life. Postoperative pain outcomes will be compared with the other study groups.",[18],"Drug: ibuprofen",{"label":20,"type":21,"description":22,"interventionNames":23},"Standard Care Control","NO_INTERVENTION","Participants randomized to this arm will not receive preoperative analgesic medication. Postoperative pain management will follow the institution's standard care protocol after completion of the surgical procedure. Outcomes will be compared with participants receiving preemptive intravenous analgesic interventions.",null,[25,33],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Acetaminophen","Acetaminophen 1 g administered intravenously approximately 30 minutes prior to surgical incision during orthognathic surgery under general anesthesia. A second dose will be administered near the end of the surgical procedure according to the medication half-life.",[9],[31,32],"Acetaminophen 1g Iv","Acetaminophen 1000mg IV",{"type":26,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"ibuprofen","Ibuprofen 600 mg administered intravenously approximately 30 minutes prior to surgical incision during orthognathic surgery under general anesthesia. A second dose will be administered near the end of the surgical procedure according to the medication half-life.",[15],[38],"Ibuprofen 600mg IV",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Dennys Rivera Pérez, MD","CONTACT","7877582525","1920-1921","dennys.rivera@upr.edu",{"name":47,"role":42,"phone":48,"phoneExt":23,"email":49},"Alvara J Horta Caicedo, DMD","1-678-394-7721","alvaro.horta@upr.edu",[51],{"facility":52,"status":23,"city":53,"state":23,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Administración de Servicios Médicos (ASEM)","San Juan","00936","Puerto Rico","PR",{"type":58,"coordinates":59},"Point",[60,61],-66.10572,18.46633,{"lat":61,"lon":60},[64,65],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},{"name":47,"role":42,"phone":48,"phoneExt":23,"email":49},{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","DENNYS RIVERA PEREZ","Assistant Professor","100636866","phase-4-impact-of-preemptive-analgesia-on-postoperative-pain-in-orthognathic-surgery-100636866",false,"NCT07571252","Impact of Preemptive Analgesia on Postoperative Pain in Orthognathic Surgery","Impact of Preemptive Analgesia on Postoperative Pain in Patients Undergoing Orthognathic Surgery: A Randomized Controlled Trial.","Inclusion Criteria:\n\n* Adults aged 21 to 65 years.\n* American Society of Anesthesiologists (ASA) physical status I or II.\n* Scheduled to undergo orthognathic surgery including bilateral sagittal split osteotomy and Le Fort I osteotomy under general anesthesia.\n* Ability to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding.\n* Known allergy or intolerance to acetaminophen, ibuprofen, or other nonsteroidal anti-inflammatory drugs (NSAIDs).\n* Renal dysfunction, defined as estimated glomerular filtration rate \\\u003C60 mL\u002Fmin\u002F1.73 m².\n* Hepatic dysfunction, defined as liver enzyme levels greater than twice the upper limit of normal.\n* History of bleeding disorders or coagulopathy.\n* Active or recent peptic ulcer disease.\n* Current use of recreational drugs, including cannabis, that in the judgment of the investigators could interfere with anesthesia management, postoperative pain assessment, or study outcomes.\n* Any medical condition that, in the judgment of the investigators, would make participation unsafe or interfere with study participation.","ALL","21 Years","65 Years",{"count":81,"type":82},72,"ESTIMATED","INTERVENTIONAL",[85],"PHASE4","This randomized controlled clinical trial evaluates the effect of preemptive analgesia on postoperative pain outcomes in adult patients undergoing orthognathic surgery. Participants scheduled for bilateral sagittal split osteotomy and Le Fort I osteotomy under general anesthesia will be randomized to one of three groups: intravenous acetaminophen, intravenous ibuprofen, or a control group receiving standard postoperative analgesia without preoperative medication.\n\nThe study aims to determine whether the administration of pre-surgical analgesics reduces postoperative pain intensity and analgesic requirements during the early postoperative period. Pain will be assessed using a standardized pain scale at multiple time points following surgery, and secondary outcomes will include postoperative analgesic consumption and patient satisfaction with pain control.\n\nThis investigation seeks to contribute evidence supporting multimodal analgesic strategies and improved postoperative pain management in patients undergoing orthognathic surgery.",[88,89],"Post Operative Pain","Orthognathic Surgery",[91,89,92,93,94,95],"Preemptive Analgesia","Postoperative Pain","Maxillofacial Surgery","Multimodal Analgesia","Randomized controlled trial","NOT_YET_RECRUITING","2026-04-29",{"date":99,"type":100},"2026-05-06","ACTUAL",{"date":102,"type":82},"2026-04",{"date":104,"type":82},"2027-02",{"name":5,"class":6},1]