[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520028":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":38,"centralContacts":42,"locations":48,"responsibleParty":64,"collaborators":67,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":34,"enrollmentInfo":81,"targetDuration":34,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":93,"overallStatus":51,"whyStopped":34,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Fentanyl IV","ACTIVE_COMPARATOR","Opioid analgesic Form: fentanyl solution for injection\u002Finfusion Administration: intravenous Initial dose: 1 ug\u002Fkg Second dose (if required): 0.6ug\u002Fkg",[13],"Drug: Fentanyl Citrate",{"label":15,"type":16,"description":17,"interventionNames":18},"Fentanyl IN","EXPERIMENTAL","Opioid analgesic Form: fentanyl solution for injection\u002Finfusion Administration: intranasal using nasal atomizer Initial dose: 1.25 ug\u002Fkg to a maximum of 100ug Second dose (if required): 1ug\u002Fkg to a maximum total dose of 2ug\u002Fkg",[13],{"label":20,"type":16,"description":21,"interventionNames":22},"Esketamine IV","Anesthetic, in lower doses the analgesic effect is dominant Form: esketamine solution for injection\u002Finfusion Administration: intravenous Initial dose: 0.2mg\u002Fkg Second dose (if required): 0.12mg\u002Fkg",[23],"Drug: Esketamine",{"label":25,"type":16,"description":26,"interventionNames":27},"Esketamine IN","Anesthetic, in lower doses the analgesic effect is dominant Form: esketamine solution for injection\u002Finfusion Administration: intranasal using a nasal atomizer Initial dose: 0.625mg\u002Fkg to a maximum of 50mg Second dose (if required): 0.5mg\u002Fkg to a maximum total dose of 1mg\u002Fkg",[23],[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Fentanyl Citrate","Subjects receive one dose of study medication (fentanyl or esketamine) at baseline, either intravenous or intranasal",[15,9],null,{"type":30,"name":36,"description":32,"armGroupLabels":37,"otherNames":34},"Esketamine",[25,20],[39],{"name":40,"affiliation":5,"role":41},"Markus W Hollmann, Prof. dr. dr.","PRINCIPAL_INVESTIGATOR",[43],{"name":44,"role":45,"phone":46,"phoneExt":34,"email":47},"Robert P Weenink, PhD","CONTACT","+31 205669111","forepain@amsterdamumc.nl",[49],{"facility":50,"status":51,"city":52,"state":34,"zip":34,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Ambulance Amsterdam","RECRUITING","Amsterdam","Netherlands","NL",{"type":56,"coordinates":57},"Point",[58,59],4.88969,52.37403,{"lat":59,"lon":58},[62],{"name":63,"role":45,"phone":34,"phoneExt":34,"email":47},"Midas de Grunt, MD",{"type":41,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Robert Weenink","Principal Investigator",[68,71],{"name":69,"class":70},"Stichting ZiektekostenVerzekering Krijgsmacht","UNKNOWN",{"name":50,"class":70},"100520028","phase-3-fentanyl-or-esketamine-for-traumatic-pain-fore-pain-trial-100520028",false,"NCT06051227","Fentanyl or Esketamine for Traumatic PAIN (FORE-PAIN) Trial","FORE-PAIN","Inclusion Criteria:\n\n* age ≥ 18 years\n* pain has been caused by a trauma (any trauma mechanism) that occurred on the same day\n* Emergency Medical Services personnel determines that administration of a strong opioid or esketamine for analgesia is required\n* patient will be transported to a hospital\n\nExclusion Criteria:\n\n* (estimated) weight \\\u003C40 or \\>100 kg\n* subject does not understand Dutch or English\n* inability to report pain score\n* inability to give IN or IV medication\n* known severe cardiovascular disease\n* pre-eclampsia\n* Glasgow Coma Scale score \\\u003C 11\n* subject is known to have previously declined participation in medical research","ALL","18 Years",{"count":82,"type":83},608,"ESTIMATED","INTERVENTIONAL",[86],"PHASE3","Fentanyl and esketamine are both standard of care for treatment of acute severe traumatic pain in the prehospital setting in the Netherlands. However, it is not known whether they are equally effective and safe. It is also not known whether intranasal (IN) administration of fentanyl or esketamine is equally effective and safe as intravenous (IV) administration.\n\nThe FORE-PAIN trial is a double-blind multi-arm randomized non-inferiority trial comparing Fentanyl IN, esketamine IV and esketamine IN (intervention arms) to fentanyl IV (comparator arm) for prehospital management of traumatic pain. The investigators hypothesize that all intervention arms provide analgesia that is non-inferior to the comparator arm, and that all study arms are equally safe.",[89,90,91,36,92],"Acute Pain Due to Trauma","Analgesia","Fentanyl","Emergency Medical Services",[94,95,96,97,98,99,100],"Analgesics","Ketanest","Administration, intranasal","Administration, intravenous","Pain management","Drug-Related Side Effects and Adverse Reactions","Anesthetics","2025-01-28",{"date":103,"type":104},"2025-01-30","ACTUAL",{"date":106,"type":104},"2024-01-11",{"date":108,"type":83},"2026-03",{"name":5,"class":6},1]