[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555621":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":62,"collaborators":10,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":10,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":10,"enrollmentInfo":75,"targetDuration":10,"studyType":78,"phases":10,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":48,"whyStopped":10,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Consultation",null,"Patient who were administered sufentanil in acute trauma by paramedics after phone call consultation with medical doctor.",[13],"Drug: Sufentanil intravenous administration followed consultation of remote physician",{"label":15,"type":10,"description":16,"interventionNames":17},"Competency","Patient who were administered sufentanil in acute trauma by paramedics based on their competencies.",[18],"Drug: Sufentanil intravenous administration based on paramedic competency",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Sufentanil intravenous administration followed consultation of remote physician","Intravenous administration of sufentanil to patients with acute injury by paramedics only after phone-call consultation of medical doctor.",[9],[9],{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Sufentanil intravenous administration based on paramedic competency","Intravenous administration of sufentanil to patients with acute injury by paramedics based on their competencies",[15],[15],[32],{"name":33,"affiliation":34,"role":35},"Jiří Smetana, MD","Zdravotnická záchranná služba Karlovarského kraje, příspěvková organizace","STUDY_DIRECTOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":10,"email":41},"Roman Sýkora, PhD","CONTACT","+420602524203","roman.sykora@zzskvk.cz",{"name":43,"role":39,"phone":44,"phoneExt":10,"email":45},"David Peřan, PhD","+420728315535","david.peran@zzskvk.cz",[47],{"facility":34,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":10,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Karlovy Vary","Karlovy Vary Region","36006","Czechia",{"type":54,"coordinates":55},"Point",[56,57],12.87117,50.23271,{"lat":57,"lon":56},[60,61],{"name":38,"role":39,"phone":40,"phoneExt":10,"email":41},{"name":43,"role":39,"phone":44,"phoneExt":10,"email":45},{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Roman Sýkora, MD, Ph.D.","Researcher, physician","100555621","safety-and-efficacy-of-sufentanil-administration-by-paramedics-in-acute-trauma-100555621",false,"NCT06514469","Safety and Efficacy of Sufentanil Administration by Paramedics in Acute Trauma","Safety and Efficacy of Sufentanil Administration by Paramedics in Acute Trauma in Prehospital Setting: Observational Study","Inclusion Criteria:\n\n* acute trauma with severe pain (VAS\u002FNRS \\> 4)\n* age \\> 18 years\n* conscious patient (GCS = 15; alert in AVPU)\n* haemodynamically stable patient (\\> 100mmHg of systolic blood pressure, \\> 60\u002Fmin of heart rate)\n\nExclusion Criteria:\n\n* EMS doctor on site\n* paediatric patient (less than 18 years)\n* predominantly chronic but not acute pain\n* incomplete documentation\n* other than traumatic reasons for opioid administration (eg. acute coronary syndrome)","ALL","18 Years",{"count":76,"type":77},300,"ESTIMATED","OBSERVATIONAL","The safety and efficacy of competence of paramedics to administer sufentanil intravenously in adult acute trauma patients without presence or without phone-call consult with an emergency medical doctor will be assessed in this observational study.\n\nCondition or disease: pain in trauma or injury. Intervention\u002Ftreatment: sufentanil administered by paramedics after the phone call consultation of medical doctor versus sufentanil administered by paramedics based on their competency, without consultation of medical doctor.",[81,82],"Injury Traumatic","Pain, Acute",[84,85,86,87,88,89],"sufentanil","acute trauma","pain","paramedic","competence","prehospital","2024-07-16",{"date":92,"type":93},"2024-07-23","ACTUAL",{"date":95,"type":93},"2024-07-01",{"date":97,"type":77},"2025-03-31",{"name":5,"class":6},1]