[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596523":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":29,"responsibleParty":52,"collaborators":55,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":25,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":32,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Mount Sinai Hospital, Canada","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"3ml of Methoxyflurane","EXPERIMENTAL","3ml of Methoxyflurane via a Penthrox inhaler",[13],"Drug: Methoxyflurane - Penthrox",{"label":15,"type":16,"description":17,"interventionNames":18},"3ml of normal saline","PLACEBO_COMPARATOR","3ml of normal saline via an identical placebo Penthrox inhaler",[19],"Other: Placebo Penthrox inhaler",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DRUG","Methoxyflurane - Penthrox",[9],null,{"type":6,"name":27,"description":17,"armGroupLabels":28,"otherNames":25},"Placebo Penthrox inhaler",[15],[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"OPG","RECRUITING","Toronto","Ontario","M5G 1Z5","Canada","CA",{"type":39,"coordinates":40},"Point",[41,42],-79.39864,43.70643,{"lat":42,"lon":41},[45,50],{"name":46,"role":47,"phone":48,"phoneExt":25,"email":49},"Dr. Mara Sobel, MD","CONTACT","416-586-8273","Mara.Sobel@sinaihealth.ca",{"name":46,"role":51,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"type":51,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Mara Sobel","Principal Investigator (Dr.)",[56],{"name":57,"class":58},"Matthew Morton Research Award","UNKNOWN","100596523","methoxyflurane-for-iud-insertion-and-endometrial-biopsy-100596523",false,"NCT07046572","Methoxyflurane for IUD Insertion and Endometrial Biopsy","A Double-blind Placebo-controlled Randomized Controlled Trial (RCT) of 3ml Methoxyflurane for Intrauterine Device (IUD) Insertion and Endometrial Biopsy","Inclusion Criteria\n\n* Any participant ≥18 years and ≤ 65 years presenting for an IUD insertion or endometrial biopsy\n* For IUD insertion, only nulliparous patients\n* English speaking participants only\n* Availability of a ride home from the appointment\n\nExclusion Criteria\n\n* Use of pain medication that is not an NSAID or acetaminophen (e.g. opioids, benzodiazepines) within past 24 hours\n* Misoprostol administration within 24 hours\n* Breastfeeding\n* Any diagnosed chronic pain syndromes (e.g. fibromyalgia, vaginismus)\n* Allergy to methoxyflurane\n* Renal or liver disease\n* Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives\n* Baseline vital signs of systolic blood pressure \\\u003C100, diastolic blood pressure \\\u003C60 and\u002For pulse \\\u003C60.\n* Previous unsuccessful office attempt of IUD insertion or endometrial biopsy by the same practitioner (note of clarification: previous unsuccessful IUD insertion or biopsy attempt by a different practitioner will still be eligible)\n* Clinically evident respiratory impairment",true,"FEMALE","18 Years","65 Years",{"count":71,"type":72},174,"ESTIMATED","INTERVENTIONAL",[75],"NA","The aim of this study is to determine if 3ml of inhaled Methoxyflurane, in the form of a Penthrox inhaler, reduces pain during IUD insertion and\u002For endometrial biopsy. The proposed study is a double-blind, placebo-controlled RCT.\n\nEach participant will be randomly assigned to one of two arms:\n\n1. Intervention (3ml of Methoxyflurane via a Penthrox inhaler)\n2. Placebo (3ml of normal saline via an identical placebo Penthrox inhaler)\n\nThe primary outcome is global pain score, which will be patient-reported by the 100 mm Visual Analogue Scale (VAS) 5-minutes following the procedure (endometrial biopsy or IUD insertion).",[78,79],"Endometrial Biopsy","Intrauterine Devices",[81],"methoxyflurane","2025-07-28",{"date":84,"type":85},"2025-07-30","ACTUAL",{"date":87,"type":85},"2025-07-24",{"date":89,"type":72},"2026-03-01",{"name":5,"class":6},1]