[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06513208":3,"trial-entities:NCT06513208":103,"trial-summary:NCT06513208":107},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":43,"secondary_outcomes":47,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":55,"eligibility_criteria":56,"std_ages":74,"locations":77,"central_contacts":95,"overall_officials":100,"references":101,"see_also_links":102},"NCT06513208","HP-00109853","Ketorolac Effects on Post-operative Pain and Lumbar Fusion","Ketorolac Effects on Post-operative Pain and Lumbar Fusion: a Double Blind Randomized Controlled Trial","RECRUITING","2027-06","2025-12","2025-12-22","2026-01","University of Maryland St. Joseph Medical Center","OTHER",false,"A double blind prospective randomized trial of IV ketorolac vs. placebo in management of patients undergoing lumbar one or two level spinal fusions.",null,[19],"Lumbar Spinal Fusion",[21,22,23],"ketorolac","toradol","lumbar spine fusion","INTERVENTIONAL","TREATMENT",[27],"PHASE4",{"count":29,"type":30},140,"ESTIMATED",[32,38],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","Ketorolac Tromethamine","IV Ketorolac 15mg every 6 hours, x 4 doses",[37],"Ketorolac arm",{"type":33,"name":39,"description":40,"armGroupLabels":41},"Placebo","IV saline as placebo",[42],"Placebo Arm",[44],{"measure":45,"timeFrame":46},"Ketorolac results in decreased post-op opioid use when administered in the first 48 hours (measured by calculating the total amount of MME utilized during the patient's inpatient stay and comparing the control and experimental groups).","12 months",[48,50],{"measure":49,"timeFrame":46},"Ketorolac use does not decrease spinal fusion rates in one or two level fusion (failure defined as by > than 2 degrees motion on standardized flexion\u002Fextension x-rays compared to pre-op imaging analyzed by SpineCAMP software at 6 and 12 months post-op).",{"measure":51,"timeFrame":46},"Ketorolac use decreases average length of hospital stay (length of stay for both the control group and the experimental group will be counted, and a statistical average for each group will be calculated and compared).","ALL","18 Years","85 Years",true,{"inclusion":57,"exclusion":63,"raw_text":73},[58,59,60,61,62],"18-85 years old (inclusive)","Elective posterior lumbar instrumented fusion","One or two level fusion","Consent to participate in study and willing to adhere to study follow up","English proficiency",[64,65,66,67,68,69,70,71,72],"\\\u003C 18 or \\> 85 years old","History of renal failure, dialysis, or creatinine over 1.50 mg\u002Fdl","Active or recent smoker (active within past 6 months)","Revision surgery","Auto\u002Fworker compensation","Active cancer or history of chemotherapy in past 6 months","Active narcotic use within 3 months of surgery date","Infection at operative levels","Any allergies to NSAIDs or Opioids","Inclusion Criteria:\n\n* 18-85 years old (inclusive)\n* Elective posterior lumbar instrumented fusion\n* One or two level fusion\n* Consent to participate in study and willing to adhere to study follow up\n* English proficiency\n\nExclusion Criteria:\n\n* \\\u003C 18 or \\> 85 years old\n* History of renal failure, dialysis, or creatinine over 1.50 mg\u002Fdl\n* Active or recent smoker (active within past 6 months)\n* Revision surgery\n* Auto\u002Fworker compensation\n* Active cancer or history of chemotherapy in past 6 months\n* Active narcotic use within 3 months of surgery date\n* Infection at operative levels\n* Any allergies to NSAIDs or Opioids",[75,76],"ADULT","OLDER_ADULT",[78],{"facility":13,"status":8,"city":79,"state":80,"zip":81,"country":82,"contacts":83,"geoPoint":92},"Towson","Maryland","21204","United States",[84,89],{"name":85,"role":86,"phone":87,"email":88},"Sam Rudow","CONTACT","410-427-5459","samuel.rudow@umm.edu",{"name":90,"role":91},"Justin Tortolani, MD","PRINCIPAL_INVESTIGATOR",{"lat":93,"lon":94},39.4015,-76.60191,[96,99],{"name":97,"role":86,"phone":87,"email":98},"Aja Janyavula","ajanyavula@umm.edu",{"name":85,"role":86,"phone":87,"email":88},[],[],[],{"nct_id":4,"conditions":104,"biomarkers":106},[105],"Lumbar spinal fusion",[],{"nct_id":4,"found":55,"summary":108,"prompt_version":118},{"design":109,"status":110,"heading":111,"summary":112,"follow_up":113,"word_count":114,"commitments":115,"compensation":116,"drugs_mentioned":117},"This is a double-blind, randomized study, meaning neither you nor your doctors will know if you are receiving Ketorolac Tromethamine or a placebo. It plans to include 140 participants.","completed","Ketorolac for Pain After Lumbar Spinal Fusion","This study is looking at whether Ketorolac Tromethamine (an IV medication) can help reduce the amount of pain medication (opioids) needed after lumbar spinal fusion surgery. You may be able to join if you are between 18 and 85 years old, are having elective posterior lumbar instrumented fusion surgery (a type of back surgery), and can speak English. You cannot join if you have kidney problems. Half of the participants will receive Ketorolac Tromethamine and the other half will receive a placebo (an inactive substance like saline). The main goal is to see if Ketorolac Tromethamine leads to less opioid use in the first 48 hours after surgery. The study is currently unclear on its recruitment status.","The study will measure opioid use during your hospital stay and compare groups at 12 months.",117,"Not specified in the trial record.","Not stated in the trial record.",[34,39],"v2"]