[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100348956":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":66,"centralContacts":70,"locations":79,"responsibleParty":96,"collaborators":55,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":55,"eligibilityCriteria":104,"healthyVolunteers":101,"sex":105,"minAge":106,"maxAge":55,"enrollmentInfo":107,"targetDuration":55,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":120,"overallStatus":82,"whyStopped":55,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"St. Louis University","OTHER",[8,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Arm","EXPERIMENTAL","For the first 24 hours following surgery, patients younger than 65 years old will be administered a maximum of 120 mg\u002Fday bolus IV ketorolac (30 mg every 6 hours). Patients older than 65 years old or with history of advanced renal impairment will receive a maximum of 60 mg\u002Fday bolus IV ketorolac (15 mg every 6 hours). All patients may also be given acetaminophen 500 mg PO Q4 hours PRN for mild pain, oxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate- severe pain, and morphine IV PRN (or other opioid) for severe breakthrough pain while hospitalized. At discharge, they will be prescribed 1-2 hydrocodone-acetaminophen 5-325 mg Q4 hours, quantity 50. Those with preexisting liver disease will be prescribed the equivalent in oxycodone and will not receive acetaminophen for mild pain.",[13,14,15,16,17,18],"Drug: Ketorolac","Drug: Acetaminophen","Drug: Oxycodone Acetaminophen","Drug: Morphine","Drug: Hydrocodone\u002FAcetaminophen","Drug: Oxycodone",{"label":20,"type":21,"description":22,"interventionNames":23},"Control","PLACEBO_COMPARATOR","Following surgery, patients will be given acetaminophen 500 mg PO Q4 hours PRN for mild pain, oxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate-severe pain, and morphine IV PRN (or other opioid) for severe breakthrough pain while hospitalized. They will also be given a placebo injection of normal saline every 6 hours for the first 24 hours following surgery. At discharge, patients will be prescribed 1-2 hydrocodone-acetaminophen 5-325 mg Q4 hours PRN quantity 50, unless they have preexisting liver disease, in which case they will be prescribed the equivalent in oxycodone. They will not receive a nerve block.",[24,14,15,16,17,18],"Drug: Normal saline",[26,33,39,45,51,56,62],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Ketorolac","IV Ketorolac to be given over the course of the first 24 hours after surgery. See arm\u002Fgroup description for further details.",[9],[32],"Toradol",{"type":27,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Normal saline","An IV normal saline placebo prepared by the hospital pharmacy.",[20],[38],"Placebo",{"type":27,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Acetaminophen","acetaminophen 500 mg PO Q4 hours PRN for mild pain",[20,9],[44],"Tylenol",{"type":27,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Oxycodone Acetaminophen","oxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate to severe pain",[20,9],[50],"Percocet",{"type":27,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"Morphine","morphine IV PRN (or other opioid) for severe breakthrough pain",[20,9],null,{"type":27,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"Hydrocodone\u002FAcetaminophen","At discharge, patients will be prescribed 1-2 hydrocodone-acetaminophen 5-325 mg Q4 hours. Those with preexisting liver disease will be prescribed the equivalent in oxycodone.",[20,9],[61],"Norco",{"type":27,"name":63,"description":64,"armGroupLabels":65,"otherNames":55},"Oxycodone","Upon discharge, patients will be prescribed the equivalent of 1-2 hydrocodone 5mg Q4 hours upon should they have preexisting liver disease and are unable to consume acetaminophen.",[20,9],[67],{"name":68,"affiliation":5,"role":69},"David Greenberg, MD","PRINCIPAL_INVESTIGATOR",[71,75],{"name":68,"role":72,"phone":73,"phoneExt":55,"email":74},"CONTACT","314-617-3410","david.greenberg@health.slu.edu",{"name":76,"role":72,"phone":77,"phoneExt":55,"email":78},"Allison Gruender, MSN","314-617-3406","allison.gruender@health.slu.edu",[80],{"facility":81,"status":82,"city":83,"state":84,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"Saint Louis University","RECRUITING","St Louis","Missouri","63110","United States","US",{"type":89,"coordinates":90},"Point",[91,92],-90.19789,38.62727,{"lat":92,"lon":91},[95],{"name":76,"role":72,"phone":77,"phoneExt":55,"email":78},{"type":69,"investigatorFullName":97,"investigatorTitle":98,"investigatorAffiliation":5,"oldNameTitle":55,"oldOrganization":55},"David D. Greenberg, MD; Professor","Professor, Orthopaedic Surgery","100348956","phase-3-post-op-pain-control-for-prophylactic-intramedullary-nailing-100348956",false,"NCT03823534","Post-Op Pain Control for Prophylactic Intramedullary Nailing.","Inclusion Criteria:\n\n1. Femoral Shaft or Neck bone lesion\n2. 18 years old or greater\n3. Plan to undergo prophylactic intramedullary nailing of one femur\n\nExclusion Criteria:\n\n1. Concurrent pathologic fracture\n2. History of advanced renal impairment (eGFR\\\u003C30mL\u002Fmin)\n3. History of Peptic Ulcer Disease with bleeding or requiring hospitalization\n4. History of NSAID or aspirin allergy\n5. Concurrent chemotherapy regimen that prevents NSAID use\n6. History of liver disease that precludes use of toradol\n7. History of heart failure or cardiovascular disease that precludes toradol usage\n8. Pregnancy\n9. History of narcotic allergy resulting in anaphylaxis\n10. Patients with coagulation disorders or those who require concomitant use of anticoagulant or anti- platelet therapy during the treatment phase of the study.\n11. Patients with acetaminophen allergies resulting in anaphylaxis\n12. Current use of the medication probenecid\n13. Current use of the medication Pentoxifylline\n14. History of aspirin induced asthma.\n15. Known history of opioid dependence, abuse, or addiction.\n16. Bilateral IMN of the femurs","ALL","18 Years",{"count":108,"type":109},60,"ESTIMATED","INTERVENTIONAL",[112],"PHASE3","Nationally, the opioid crisis has become a major epidemic with increasing mortality rates each year. Orthopedic surgeons routinely prescribe narcotics instead of NSAIDs for post-op pain control because of risk of delayed healing and nonunion due to NSAID use. Orthopedic oncology, however, has a unique subset of patients that undergo prophylactic placement of intramedullary femoral nails. Because no fracture is present, these patients do not rely on inflammatory healing factors, allowing for post-op NSAID use. This study sets out to determine the effect of post-op toradol use in addition to opioids compared to solely opioids in patients undergoing prophylactic nailing of the femur.",[115,116,117,118,119],"Bone Metastases","Lymphoma","Multiple Myeloma","Opioid Use","Pain",[32,28,121,122,123,124],"Prophylactic intramedullary nail","bone metastases","Opioid use","post-operative pain","2026-04-17",{"date":127,"type":128},"2026-04-22","ACTUAL",{"date":130,"type":128},"2019-02-20",{"date":132,"type":109},"2027-03-31",{"name":5,"class":6},1]