[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617117":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":29,"responsibleParty":81,"collaborators":84,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":10,"enrollmentInfo":100,"targetDuration":10,"studyType":103,"phases":10,"briefSummary":104,"conditions":105,"keywords":116,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Region Zealand","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Extremity injuries",null,"Each department will collect data on the treatment patients with the upper and lower extremity injuries receive during reduction or stabilizing treatment (procedural sedation and\u002For analgesia, or no treatment).",[13],"Drug: Usual Care",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DRUG","Usual Care","No intervention: Patients will receive usual care",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Sophie Sværke, MD","CONTACT","31368854","Ibes@regionsjaelland.dk",{"name":27,"role":23,"phone":10,"phoneExt":10,"email":28},"Ole Mathiesen, Professor","Omat@regionsjaelland.dk",[30,53,67],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Emergency Department, Holbæk Hospital","RECRUITING","Holbæk","Region Sjælland","4600","Denmark","DK",{"type":39,"coordinates":40},"Point",[41,42],11.71279,55.7175,{"lat":42,"lon":41},[45,48,51],{"name":46,"role":23,"phone":10,"phoneExt":10,"email":47},"Anders Krusenstjerna-Hafstrøm, MD","Andh@regionsjaelland.dk",{"name":49,"role":50,"phone":10,"phoneExt":10,"email":10},"Martin Schou, MD","PRINCIPAL_INVESTIGATOR",{"name":46,"role":52,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"facility":54,"status":32,"city":55,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Emergency Department, Zealand University Hospital","Køge",{"type":39,"coordinates":57},[58,59],12.18214,55.45802,{"lat":59,"lon":58},[62,65],{"name":63,"role":23,"phone":10,"phoneExt":10,"email":64},"Marie-Laure Bouchy Jacobsson","majaco@regionsjaelland.dk",{"name":66,"role":50,"phone":10,"phoneExt":10,"email":10},"Marie-Laure Bouchy Jacobsson, MD",{"facility":68,"status":32,"city":69,"state":70,"zip":71,"country":36,"countryCode":37,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Emergency Department, Odense University Hospital","Odense","Region Syddanmark","5000",{"type":39,"coordinates":73},[74,75],10.38831,55.39594,{"lat":75,"lon":74},[78],{"name":79,"role":23,"phone":10,"phoneExt":10,"email":80},"Mikkel Brabrand, Professor","mikkel.brabrand@rsyd.dk",{"type":50,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Sophie Sværke","Principal Investigator",[85,87,89],{"name":86,"class":6},"Zealand University Hospital",{"name":88,"class":6},"Odense University Hospital",{"name":90,"class":6},"Holbaek Sygehus","100617117","procedural-sedation-and-analgesia-for-treatment-of-adults-with-fractures-and-dislocations-in-the-emergency-department-100617117",false,"NCT07314450","Procedural Sedation and Analgesia for Treatment of Adults With Fractures and Dislocations in the Emergency Department","PAINEX","Inclusion Criteria:\n\n1. Age ≥18.\n2. Patients with the following injuries are eligible:\n\n   1. Reduction treatment of shoulder dislocation\n   2. Reduction treatment of elbow dislocation\n   3. Reduction treatment of distal radius fractures, application of cast\n   4. Reduction treatment of finger fractures\u002Fdislocation\n   5. Casting treatment of upper extremity fractures\n\n      * Proximal humerus fracture, application of fixed sling\n      * Humeral shaft fracture, application of Sarmiento brace\n      * Supracondylar fracture, application of angled cast\n   6. Reduction treatment of hip dislocation\n   7. Reduction treatment of patella dislocation\n   8. Reduction of tibial shaft fracture, application of cast\n   9. Reduction treatment of ankle fractures including distal tibia fracture\n   10. Reduction treatment for toe fractures\u002Fdislocation\n   11. Casting treatment of lower extremity fractures\n\n       * Distal femur fracture, application of cast\u002Ftraction\n       * Proximal tibia fracture, application of cast or hinged brace\n       * Ankle fracture, application of walker\n\nExclusion Criteria:\n\n1. Unable to give informed consent (e.g. unconscious, psychotic or dementia)\n2. Unwilling to participate in the study\n3. Prior inclusion in the study\n4. Already included in another clinical study at the same day\u002Fhospital visit\n5. Pregnant or breastfeeding","ALL","18 Years",{"count":101,"type":102},200,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to evaluate the effectiveness and safety of different procedural sedation and analgesia methods used for adults with painful fractures requiring reduction treatment in the emergency department.\n\nThe main questions it aims to answer are:\n\n* Which sedation and analgesia methods provide the best patient satisfaction and pain relief?\n* How do different treatment methods affect clinician satisfaction and the occurrence of adverse events?\n\nThe investigators will compare different types of procedural sedative and analgesic treatments (such as systemic sedation\u002Fanalgesia and regional techniques like nerve or hematoma blocks) to see which approach offers the best patient satisfaction and most effective pain control.\n\nParticipants will:\n\nBe adult patients with upper or lower extremity fractures or joint dislocations requiring painful reduction procedures.\n\nReceive one of the routinely used sedation or analgesia treatments (or no analgesia) during their emergency department care.\n\nReport their pain levels and satisfaction before, during, and after treatment. Be monitored for any side effects, complications, or use of antidotes. Data will be collected over a six-month period at Odense University Hospital, Holbæk Hospital, and Zealand University Hospital, Køge, following the STROBE guidelines for observational studies.",[106,107,108,109,110,111,112,113,114,115],"Pain, Procedural","Analgesia","Extremity Injury","Patient Satisfaction","Satisfaction, Personal","Satisfaction","Upper Extremity Injury","Lower Extremity Fracture","Upper Extremity Fracture","Extremity Injuries Lower",[117,118],"Emergency Department","Procedural sedation and analgesia","2025-12-17",{"date":121,"type":122},"2026-01-02","ACTUAL",{"date":124,"type":122},"2025-07-29",{"date":126,"type":102},"2026-07-01",{"name":5,"class":6},3]