[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544104":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":37,"locations":47,"responsibleParty":65,"collaborators":42,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":42,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":49,"whyStopped":42,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Maimonides Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Nebulized KetaBAN","ACTIVE_COMPARATOR","Nebulized ketamine administered at 0.75 mg\u002Fkg via BAN to adult patients presenting to the ED of Maimonides Medical Center with acute painful conditions of moderate to severe intensity.",[13],"Drug: Ketamine",{"label":15,"type":10,"description":16,"interventionNames":17},"Nebulized FentaBAN","Nebulized fentanyl administered at 3 mcg\u002Fkg via BAN to adult patients presenting to the ED of Maimonides Medical Center with acute painful conditions of moderate to severe intensity.",[18],"Drug: Fentanyl",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Ketamine","Nebulized ketamine administered at 0.75 mg\u002Fkg via BAN",[9],[26],"Ketalar",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Fentanyl","Nebulized fentanyl administered at 3 mcg\u002Fkg via BAN",[15],[32],"Sublimaze",[34],{"name":35,"affiliation":5,"role":36},"Sergey Motov, MD","PRINCIPAL_INVESTIGATOR",[38,44],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Antonios Likourezos, MA, MPH","CONTACT","718-283-6896",null,"alikourezos@maimo.org",{"name":35,"role":40,"phone":45,"phoneExt":42,"email":46},"718-283-8693","smotov@maimo.org",[48],{"facility":5,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Brooklyn","New York","11219","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-73.94958,40.6501,{"lat":59,"lon":58},[62,63],{"name":35,"role":40,"phone":42,"phoneExt":42,"email":46},{"name":64,"role":40,"phone":42,"phoneExt":42,"email":43},"Antonios Likourezos, MPH",{"type":66,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"SPONSOR_INVESTIGATOR","Antonios Likourezos","Research Administration Director","100544104","phase-4-nebulized-ketamine-to-nebulized-fentanyl-for-treating-acute-painful-conditions-in-the-ed-100544104",false,"NCT06364540","Nebulized Ketamine to Nebulized Fentanyl for Treating Acute Painful Conditions in the ED","Comparison of Nebulized Ketamine to Nebulized Fentanyl for Treating Acute Painful Conditions in the ED: A Prospective, Randomized, Double-Blind Clinical Trial.","KETAFEN","Inclusion Criteria:\n\n* age 18+ years\n* acute painful condition\n* pain score of 5 or more on a standard 11 point numeric rating scale (NRD)\n* patient needs to be awake, alert, and oriented as to person, place, and time\n* demonstrated understanding of the informed consent process and content\n* patient needs to demonstrate the ability to verbalize the nature of any adverse effects (AE)\n* patient needs to experience as well as express their pain severity by using the NRS\n\nExclusion Criteria:\n\n* patient with a painful condition warranting emergent\u002Furgent intervention in the ED\n* patients with altered mental status\n* allergy to ketamine or fentanyl\n* pregnant or breastfeeding\n* weight greater than 100 kg\n* patients presenting with head injury\n* unstable vital signs (systolic blood pressure \\\u003C90 mmHg or \\>180 mmHg, pulse rate \\\u003C50 beats\u002Fmin or \\>150 beats\u002Fmin, and respiration rate \\\u003C10 breaths\u002Fmin or \\>30 breaths\u002Fmin)\n* inability to provide consent\n* current medical history of alcohol or drug abuse\n* administration of opioids or opioid antagonist\u002Fagonist within 4-6 hours prior to arrival and NSAIDs 6 hours prior to arrival to the t","ALL","18 Years","120 Years",{"count":81,"type":82},150,"ESTIMATED","INTERVENTIONAL",[85],"PHASE4","In situations where intravenous access is not readily available or is unobtainable and the intranasal route is not feasible, another non-invasive route of ketamine administration, such as inhalation via breath-actuated Nebulizer (BAN), is becoming a viable alternative. The BAN allows the controlled, patient-initiated delivery of analgesics in a measured and titratable fashion. (18) Ketamine has been studied as a nebulized drug in a lot of different settings and for a lot of different reasons, such as to treat acute pain after surgery (like a sore throat after being intubated), as a pre-medication for general anesthesia, to treat cancer pain, and as a therapy for asthmaticus.\n\nOur research team has published two case series of 10 adult patients who were given nebulized ketamine (via BAN) for a variety of acute traumatic and non-traumatic painful conditions. The patients showed a 60% decrease in pain and a small number of side effects. Furthermore, our group published a randomized, double-blind trial of 120 adult patients evaluating the analgesic efficacy and safety of nebulized ketamine at three different dosing regimens for acute pain in the ED (0.75 mg\u002Fkg, 1 mg\u002Fkg, and 1.5 mg\u002Fkg), showing similar analgesic efficacy between the three different dosing regimens for short-term (up to 120 minutes) pain relief. Lastly, we recently completed a randomized, double-blind, double-dummy clinical trial comparing the analgesic efficacy and safety of nebulized ketamine and intravenous ketamine in managing acute pain in adult ED patients, with data currently being analyzed.\n\nNebulized fentanyl given in the ED to adults with acute traumatic and non-traumatic pain syndromes at a dose range of 1.5-4 mcg\u002Fkg showed the same or even better pain-relieving effects than IV fentanyl and IV morphine alone.\n\nOur objective is to compare the analgesic efficacy and rates of side effects of a 0.75 mg\u002Fkg dose of ketamine administered via breath-actuated nebulizer (BAN) to a dose of 3 mcg\u002Fkg of fentanyl administered via breath-actuated nebulizer (BAN) in adult patients presenting to the ED with acute painful conditions.",[88],"Pain, Acute",[90,91,92,93],"pain","acute","emergency medicine","clinical tiral","2025-05-30",{"date":96,"type":97},"2025-06-04","ACTUAL",{"date":99,"type":97},"2024-05-01",{"date":101,"type":82},"2026-12-31",{"name":67,"class":6},1]