[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fracture-elbow\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fracture-elbow":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100449376","cast-or-operation-for-medial-epicondyle-fracture-treatment-in-children-100449376",false,"NCT05131672","Cast or Operation for Medial Epicondyle Fracture Treatment in Children","Operative Versus Nonoperative Treatment of Pediatric Medial Epicondyle Fractures (COMET Trial - Cast or Operation for Medial Epicondyle Fracture Treatment in Children)","COMET","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form by parent or legal guardian and signed assent form if participant is older than 12 years.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged 7-17 years inclusive\n4. Diagnosis of medial epicondyle fracture with any amount of displacement\n5. Fracture is acute (occurred within 10 days of assignment of treatment arm)\n6. Ability to take oral medication and be willing to adhere to the immobilization regimen\n\nExclusion Criteria:\n\n1. Medial epicondyle fragment that is incarcerated within joint\n2. Presence of other fractures about the ipsilateral elbow\n3. Presence of pathologic fracture, open fracture\n4. Have metabolic or neuromuscular diagnosis\n5. Patient and parents are unable to adhere to procedures or complete follow-up due to insufficient comprehension of consent form or surveys or developmental delay.","ALL","7 Years","17 Years",{"count":21,"type":22},334,"ESTIMATED","INTERVENTIONAL",[25],"NA","This protocol describes a multicenter, prospective randomized and patient preference cohort superiority trial of medial epicondyle fracture treatments comparing functional outcomes between children treated with operative reduction and fixation or non-operative immobilization.",[28],"Fracture Elbow","RECRUITING","2026-06-30",{"date":32,"type":33},"2026-07-01","ACTUAL",{"date":35,"type":33},"2022-10-28",{"date":37,"type":22},"2031-07-31",{"name":39,"class":40},"Joseph Janicki","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":41},"100635444","phase-4-a-clinical-trial-on-the-use-of-lidocaine-infusion-during-surgery-for-pediatric-upper-extremity-fractures-and-its-impact-on-total-perioperative-opioid-requirements-100635444","NCT07552766","A Clinical Trial on the Use of Lidocaine Infusion During Surgery for Pediatric Upper Extremity Fractures and Its Impact on Total Perioperative Opioid Requirements","A Prospective, Randomized, Double-blind Trial of the Impact of Intraoperative Intravenous Lidocaine Infusion on Total Opioid Requirements in Children Undergoing Surgical Fixation of Upper Extremity Long Bone Fractures Under General Anesthesia","Inclusion Criteria:\n\n* Patients aged 3-18 years\n* Patients \\> 10 kg\n* Patients who present to Nemours Children's Hospital - Delaware Valley (NCH-DE) for surgical fixation of upper extremity fractures from distal humerus to distal radius\n\nExclusion Criteria:\n\n* Children \\\u003C 3 years or \\> 18 years\n* Patients with allergy to local anesthetics\n* Patients who are eligible for an receive a peripheral nerve block\n* Patients with multi-trauma or open fractures\n* Patients with previous history of seizure disorder\n* Patients with conduction abnormalities or cardiac arrhythmia requiring chronic treatment\n* Patients on strong CYP450 inhibitors (fluvoxamine, erythromycin, ciprofloxacin, rifampin, allopurinol, ketoconazole, itraconazole)\n* Patients with chronic kidney or liver dysfunction\n* Patients with planned use of continuous infusion pain medications (opioids, ketamine, alpha-2- agonists)\n* Patients with positive pregnancy test prior to surgery or nursing mothers\n* Patients who parents decline enrollment","3 Years","18 Years",{"count":52,"type":22},90,[54],"PHASE4","This study is a prospective, randomized, double-blind clinical trial evaluating whether intraoperative intravenous lidocaine infusion (IVLI) reduces opioid requirements and improves postoperative pain control in children undergoing surgical fixation of upper extremity long bone fractures under general anesthesia. Ninety pediatric patients, ages 3-18 will be enrolled and randomized 1:1 to receive either IV lidocaine or placebo (normal saline) during surgery.\n\nAll participants will receive standardized anesthesia care and postoperative pain management. Opioid consumption and pain scores will be measured intraoperatively and throughout the postoperative recovery, with the primary outcome focused on total opioid use 60 minutes after arrival to the post-anesthesia care unit (PACU). Secondary outcomes include opioid use at additional time points, postoperative pain scores, PACU length of stay, rescue antiemetic use and the relationship between infusion duration and outcomes.\n\nPatients will be closely monitored for signs of local anesthetic systemic toxicity and other adverse events. The goal of this study is to determine whether IV lidocaine is an effective opioid-sparing adjunct in pediatric orthopedic surgery and to support safer, multimodal analgesia strategies.",[57,58,28,59,60,61,62],"Fracture Arm","Fracture Closed of Lower End of Forearm, Unspecified","Fracture Fixation","Fracture Fixation, Internal","Fracture Forearm","Fracture Distal Radius","NOT_YET_RECRUITING","2026-04-22",{"date":66,"type":33},"2026-04-27",{"date":68,"type":22},"2026-05",{"date":70,"type":22},"2029-07",{"name":72,"class":40},"Nemours Children's Clinic"]