[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Naveen Poonai\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":27,"conditions":28,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100377494","phase-2-intranasal-dexmedetomidine-plus-ketamine-for-procedural-sedation-100377494",false,"NCT04195256","Intranasal Dexmedetomidine Plus Ketamine for Procedural Sedation","Intranasal Dexmedetomidine Plus Ketamine for Procedural Sedation in Children: an Adaptive Randomized Controlled Non-inferiority Multicenter Trial","Ketodex","INCLUSION CRITERIA\n\nGeneral Criteria\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Deemed by treating physician to require procedural sedation\n\nSpecific criteria\n\n1. Children presenting to the paediatric EDs of participating sites age 2-17 years\n2. Weighing up to and including 100 kg\n3. One of the following injuries:\n\n   * Closed forearm fracture\n   * Metacarpal or phalangeal fracture\n   * Dislocation of a shoulder or elbow\n   * Type II supracondylar fracture\n4. Expected to not require more than one dose of IV sedative medication if they were not in the trial (as determined by the procedure physician and not including cast or splint application).\n5. Both nares are fully patent\n6. Physician plans to sedate patient\n\nEXCLUSION CRITERIA\n\n1. Previous hypersensitivity reaction to ketamine or dexmedetomidine including rash, difficulty breathing, hypotension, apnea, or laryngospasm;\n2. Suspected globe rupture;\n3. Concomitant traumatic brain injury with intracranial hemorrhage;\n4. Uncontrolled hypertension;\n5. Nasal bone deformity or septal deviation;\n6. Poor English or French fluency in the absence of native language interpreter;\n7. American Society of Anesthesiologists (ASA) class 3 or greater;\n8. Previous diagnosis of schizophrenia or active psychosis as per the treating physician\n9. Neuro-cognitive impairment that precludes informed consent, assent, or ability to self-report pain and satisfaction;\n10. More than one fracture or dislocation requiring reduction;\n11. Hemodynamic compromise as per the treating physician;\n12. Glasgow coma score \\\u003C 15;\n13. Previous sedation with ketamine or hematoma block within 24 hours;\n14. Fracture is comminuted or associated with a dislocation;\n15. Participant has undergone a hematoma block within 24 hours;\n16. Obstructive sleep apnea\n17. Previous enrollment in the trial;\n18. Suspected pregnancy\n19. Congenital heart disease or known cardiac dysrhythmia\n20. Known or suspected hepatic impairment\n21. Known renal insufficiency\n22. Uncorrected mineralocorticoid deficiency","ALL","2 Years","17 Years",{"count":21,"type":22},400,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE2","PHASE3","Orthopedic injuries comprise more than 10% of ED visits in children and 25 to 50% of children will sustain a fracture before age 16 years. Distal radius fractures account for 20-32% of fractures in children, making them the most common fracture type. Between 20 and 40% of extremity fractures in children require a closed reduction, often necessitating procedural sedation and analgesia (PSA). Intravenous (IV) ketamine is the most commonly used sedative agent used to perform a closed reduction. However, children rate IV insertion as the most painful hospital experience, second only to the injury itself. IV insertion can be more technically difficult in children because of smaller veins and lack of cooperation, often leading to multiple IV attempts. A combination of intranasal (IN) dexmedetomidine plus ketamine (IN Ketodex) may provide effective sedation for children undergoing a closed reduction without the distress and pain related to IV insertion. A less painful experience has been found to correlate with child satisfaction which may reduce caregiver anxiety and improve the therapeutic relationship with the health care team. This study is a multi-centre, two-arm, randomized, blinded, controlled, non-inferiority trial designed to test the hypothesis that IN Ketodex is non-inferior to intravenous (IV) ketamine with respect to depth of sedation as measured using the Pediatrics Sedation State Scale (PSSS).",[29,30],"Fracture","Dislocation","RECRUITING","2024-11-01",{"date":34,"type":35},"2024-11-05","ACTUAL",{"date":37,"type":35},"2020-03-11",{"date":39,"type":22},"2026-12",{"name":41,"class":42},"Naveen Poonai","OTHER",6,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100499613","a-mobile-recovery-guidance-app-for-children-and-young-adults-with-acute-ankle-inversion-injuries-100499613","NCT05785533","A Mobile Recovery Guidance App for Children and Young Adults With Acute Ankle Inversion Injuries","A Mobile Recovery Guidance App for Children and Young Adults With Acute Ankle Inversion Injuries: a Randomized Controlled Trial","SPRAIN","Inclusion Criteria:\n\n* Age 12-30 years\n* Presenting to the Paediatric Emergency Department of the Children's Hospital or Adult Emergency Department, London Health Sciences Centre, London, or ntario, St. Joseph Urgent Care Centre, London, Ontario, with a unilateral acute (\\\u003C= 48 hours) ankle injury based on clinical diagnosis by ED physician\n* Able to use a WiFi enabled smartphone with either an iOS or Android operating system with enough memory capability to host the App.\n\nExclusion Criteria:\n\n* Unable to read or understand English above at least a grade 8 literacy level in the absence of a native language interpreter\n* Not independently ambulatory prior to injury (without the use of an assistive device)\n* Developmental disability precluding the full comprehension of study-related procedures\n* Multi-system or multi-limb injuries\n* Concomitant radiographically proven lower extremity fracture or dislocation (with the exception of a suspected Salter-Harris type I injury)","12 Years","30 Years",{"count":55,"type":22},250,[57],"NA","Ankle sprains are the most common musculoskeletal complaint of children presenting to the emergency department (ED). Healing can often be protracted, leading to prolonged pain, missed school and work, and delayed return to a normal activity level. Smartphone apps have been shown to be associated with greater caregiver knowledge and improved outcomes in a number of conditions but have not been explored in ankle sprains. We would like to know if using a smartphone app for children with ankle inversion injuries leads to improved functional outcomes such as pain, mobility, and return to activity. We will be comparing a smartphone app that provides education and daily management reminders to a paper handout to see if the former leads to improved functional recovery.",[60],"Ankle Sprains",[62,63,64],"Ankle inversion injury","Mobile app","Recovery guidance","2024-09-20",{"date":67,"type":35},"2024-09-23",{"date":69,"type":35},"2024-08-24",{"date":71,"type":22},"2026-12-31",{"name":41,"class":42},1,""]