[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573747":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":39,"responsibleParty":57,"collaborators":26,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":26,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":26,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":42,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"St. Paul's Hospital, Canada","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Penthrox","ACTIVE_COMPARATOR","3mL Penthrox as an inhaled analgesic",[13],"Drug: Methoxyflurane - Penthrox",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","3mL placebo control (saline + one drop of methoxyflurane)",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Methoxyflurane - Penthrox","3ml",[9],null,{"type":6,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"saline + one drop of methoxyflurane",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Amin Javer, MD","CONTACT","604-806-9926","sinusdoc@me.com",{"name":37,"role":33,"phone":34,"phoneExt":26,"email":38},"Leonora Beltran, MD","lbeltranjimenez@providencehealth.bc.ca",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"St Paul's Sinus Centre","RECRUITING","Vancouver","British Columbia","V6Z 1Y6","Canada","CA",{"type":49,"coordinates":50},"Point",[51,52],-123.11934,49.24966,{"lat":52,"lon":51},[55],{"name":56,"role":33,"phone":34,"phoneExt":26,"email":38},"Leonora Beltran",{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Amin Javer","Director","100573747","phase-1-effectiveness-of-penthrox-vs-placebo-in-sinus-procedures-a-clinical-trial-100573747",false,"NCT06750302","Effectiveness of Penthrox vs Placebo in Sinus Procedures, a Clinical Trial","The Effectiveness of Inhaled Methoxyflurane (Penthrox) vs Placebo for Pain Relief in Coblation and Sinus Procedures: a Double-blind, Randomized, Placebo - Controlled Trial","Inclusion Criteria:\n\n* Age 19 years or older\n* Scheduled for minor sinus surgery or coblation procedures\n\nExclusion Criteria:\n\n* Cystic fibrosis\n* Systemic vasculitis or other bleeding disorders\n* History of renal failure or severe kidney disease\n* History of liver failure or severe liver disease\n* Altered state of consciousness (head injury, alcohol use, drug use)\n* Known or suspected hypersensitivity to lidocaine or sensorcaine\n* Inhaled drug use (i.e., cocaine) in the preceding 6 months\n* Nasal tumors\n* Personal or family history of malignant hyperthermia\n* Respiratory depression","ALL","19 Years",{"count":71,"type":72},100,"ESTIMATED","INTERVENTIONAL",[75,76],"PHASE1","PHASE2","The goal of this randomized controlled trial is to evaluate the effectiveness of inhaled methoxyflurane (Penthrox) as an analgesic for patients undergoing minor rhinology and sinus procedures, specifically comparing it to a placebo control. The primary question the study aims to answer is:\n\nDoes methoxyflurane provide superior pain relief compared to placebo during minor sinus procedures, as measured by the Visual Analog Scale (VAS)? If there is a comparison group: Researchers will compare the effects of Penthrox to the placebo (saline + one drop of methoxyflurane) to see if it provides better pain relief, reduces anxiety, and leads to fewer complications, including bleeding.\n\nParticipants will be asked to:\n\nInhale 3 mL of Penthrox or placebo during their procedure. Complete a VAS scale to assess pain. Complete anxiety assessments pre- and post-operatively. Be monitored for complications such as bleeding and other adverse effects. This study will help determine the effectiveness of Penthrox as a non-invasive, quick-acting analgesic for minor sinus surgeries.",[79],"Chronic Rhinosinusitis (CRS)",[79,81,82,83,84,9,85,86],"Sinus Surgery","Endoscopic Sinus Surgery (ESS)","Coblation","Methoxyflurane","Inhaled Analgesic","Inhaled Analgesics in Rhinology","2025-05-12",{"date":89,"type":90},"2025-05-15","ACTUAL",{"date":92,"type":90},"2024-11-24",{"date":94,"type":72},"2026-06-24",{"name":5,"class":6},1]