[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615626":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":40,"locations":47,"responsibleParty":64,"collaborators":45,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":45,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":45,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":49,"whyStopped":45,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Women's College Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group","EXPERIMENTAL","Participants will receive a Penthrox inhaler containing 3 mL of methoxyflurane. Before speculum insertion, they will take intermittent inhalations every 30-60 seconds (6-10 breaths), following monograph instructions. They may continue self-administering the inhaler as needed during the procedure.\n\nParticipants will receive standard pain management prior to IUD insertion, which includes: 1) recommendation to use over-the-counter analgesics such as NSAIDs, and 2) the option to undergo a cervical block to minimize discomfort during the procedure.",[13],"Drug: Methoxyflurane",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Group","PLACEBO_COMPARATOR","Participants will receive an identical-looking inhaler containing 3 mL of normal saline. To maintain blinding, a drop of methoxyflurane will be placed on the outside of the device, which has no analgesic effect. Before speculum insertion, participants will take intermittent inhalations every 30-60 seconds (6-10 breaths), following monograph-style instructions, and may continue self-administering as needed during the procedure.\n\nParticipants will receive standard pain management prior to IUD insertion, which includes: 1) recommendation to use over-the-counter analgesics such as NSAIDs, and 2) the option to undergo a cervical block to minimize discomfort during the procedure.",[19],"Drug: Saline",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Methoxyflurane","3 mL of Methoxyflurane via a handheld inhaler",[9],[27],"Penthrox",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Saline","3 mL of Normal Saline via an identical placebo handheld inhaler",[15],[33],"0.9% sodium chloride",[35,38],{"name":36,"affiliation":5,"role":37},"Lauren Scott, NP","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":5,"role":37},"Karim Ladha, MD",[41],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"Didem Bozak","CONTACT","6473814051",null,"didem.bozak@wchospital.ca",[48],{"facility":5,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Toronto","Ontario","M5S 1B2","Canada","CA",{"type":56,"coordinates":57},"Point",[58,59],-79.39864,43.70643,{"lat":59,"lon":58},[62],{"name":42,"role":43,"phone":63,"phoneExt":45,"email":46},"416-323-6008",{"type":65,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR","100615626","phase-4-3-ml-inhaled-methoxyflurane-for-intrauterine-device-iud-insertion-100615626",false,"NCT07295054","3 mL Inhaled Methoxyflurane for Intrauterine Device (IUD) Insertion","A Double-blind Placebo-controlled Randomized Controlled Trial (RCT) of 3 mL Inhaled Methoxyflurane for Intrauterine Device (IUD) Insertion","Inclusion Criteria:\n\n1. Patients with a uterus.\n2. Ages 18 to 55 years.\n3. Undergoing any intrauterine device (IUD) insertion.\n4. English-speaking participants.\n5. Ability to use an inhaler device.\n6. Willing to receive a cervical block for their IUD insertion\n\nExclusion Criteria:\n\n1. Inability to provide informed consent.\n2. Confirmed pregnancy.\n3. Use of pain medication other than NSAIDs or acetaminophen (e.g., opioids, benzodiazepines, muscle relaxants) within 24 hours prior to the intervention.\n4. Use of cannabis within 24 hours prior to the intervention.\n5. Administration of misoprostol within 24 hours prior to the intervention.\n6. Altered level of consciousness due to any cause, including head injury, drugs, or alcohol.\n7. History of severe adverse reactions to Penthrox (methoxyflurane) or other halogenated anesthetic agents, or to any ingredient in the formulation (including non-medicinal ingredients or container components).\n8. Anatomical variance, such as distorted uterine cavity, bicornuate uterus, uterus didelphys, or cervical stenosis.\n9. Clinically significant renal and\u002For liver impairment.\n10. Known or genetic susceptibility to malignant hyperthermia.\n11. Clinically evident hemodynamic or cardiovascular instability, or respiratory depression.\n12. Not NPO according to hospital guidelines.","FEMALE","18 Years","55 Years",{"count":77,"type":78},110,"ESTIMATED","INTERVENTIONAL",[81],"PHASE4","Intrauterine device (IUD) insertion is a common contraceptive procedure often associated with moderate to severe pain, particularly among nulliparous individuals. Current pain management strategies, such as over-the-counter analgesics, are frequently inadequate. Methoxyflurane, a short-acting, self-administered inhaled analgesic, has been shown to provide rapid and effective pain relief in acute and procedural settings. This study aims to evaluate whether 3 mL of inhaled Methoxyflurane (via Penthrox inhaler) improves patient satisfaction by reducing pain and anxiety during IUD insertion.",[84],"IUD",[23,27],"2026-05-07",{"date":88,"type":89},"2026-05-11","ACTUAL",{"date":91,"type":89},"2026-04-27",{"date":93,"type":78},"2027-02",{"name":5,"class":6},1]