[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593241":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":28,"studyPopulation":31,"armGroups":32,"interventions":38,"overallOfficials":28,"centralContacts":28,"locations":28,"responsibleParty":44,"collaborators":28,"id":46,"slug":28,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":28,"enrollmentInfo":55,"targetDuration":28,"studyType":58,"phases":28,"briefSummary":59,"conditions":60,"keywords":28,"overallStatus":62,"whyStopped":28,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":28},{"fullName":5,"class":6},"Sir Mortimer B. Davis - Jewish General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"TSQM-1.4 (Treatment Satisfaction Questionnaire for Medication 1.5)","This is a validated 14-item including Likert scales and dichotomous (yes\u002Fno) items on the effectiveness, side effects, convenience and global satisfaction with the medication taken","At first follow-up visit (within 1 month post-procedure)",[14,18,21,25],{"measure":15,"description":16,"timeFrame":17},"Ability to complete intended procedure","Documented by clinic nurse post- procedure","At procedure visit",{"measure":19,"description":20,"timeFrame":17},"Modified Ramsay Sedation score","Maximal sedation score during procedure documented by clinic nurse",{"measure":22,"description":23,"timeFrame":24},"Adverse events","Either self- or physician-reported","At procedure visit and first follow-up visit (within 1 month post-procedure)",{"measure":26,"description":27,"timeFrame":17},"Visual analog pain scale","Maximal degree of pain during procedure",null,{"allocation":28,"interventionModel":28,"interventionModelDescription":28,"primaryPurpose":28,"observationalModel":6,"timePerspective":30,"maskingInfo":28},"PROSPECTIVE","All adult patients undergoing an otolaryngology proceure in the Otolaryngology clinic of the Jewish General Hospital with inhaled methoxyflurane as an adjunct to topical or local anesthesia",[33],{"label":34,"type":28,"description":35,"interventionNames":36},"Patients undergoing an otolaryngology in-office procedure using methoxyflurane","All adult patients undergoing any of the following procedures with inhaled methoxyflurane as an adjunct to topical or local anesthesia:\n\n* Skin lesion excision or reconstruction\n* Fine or core needle aspiration biopsy\n* Mucosal biopsy\n* Laryngeal injection or biopsy\n* Myringotomy with or without tympanostomy tube insertion\n* Inferior turbinate reduction\n* Septal button insertion",[37],"Drug: Methoxyflurane anesthesia",[39],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":28},"DRUG","Methoxyflurane anesthesia","A single Penthrox (3mL) self-inhaler will be administered 5-minutes prior to the onset of the procedure, before local anesthesia. Patients will undergo the procedure, have post-procedural vital signs, and remain in clinic for observation for 30 minutes post-procedure per our usual post-procedure monitoring.",[34],{"type":45,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100593241",false,"NCT07003880","Penthrox in Otolaryngology","Inhaled Methoxyflurane for In-Office Procedures in Otolaryngology","PenthroxOTL","Inclusion Criteria:\n\n* All adult patients undergoing any of the following procedures with inhaled methoxyflurane as an adjunct to topical or local anesthesia:\n\n  * Skin lesion excision or reconstruction\n  * Fine or core needle aspiration biopsy\n  * Mucosal biopsy\n  * Laryngeal injection or biopsy\n  * Myringotomy with or without tympanostomy tube insertion\n  * Inferior turbinate reduction\n  * Septal button insertion\n\nExclusion Criteria:\n\n* Patient unable to complete the post-procedure questionnaire (either due to time constraints, neurocognitive impairment, etc.)\n* Presence of any contraindications to inhaled methoxyfluorane per product monograph:\n\n  * Patients less than 18 years of age\n  * Pregnancy, intended pregnancy, or current breast-feeding\n  * Inadequate patient understanding or lack of cooperation\n  * Decreased level of consciousness or head injury\n  * History of clinically significant renal impairment, e.g., reduced renal output\n  * History of liver dysfunction following previous exposure to halogenated anesthetics\n  * Current use of tetracycline antibiotics\n  * Personal or genetic history of malignant hyperthermia\n  * Muscular dystrophy","ALL","18 Years",{"count":56,"type":57},50,"ESTIMATED","OBSERVATIONAL","Our objective is to explore the use of methoxyflurane anesthesia as an adjunct analgesic to local anesthesia during in-office otolaryngology procedures in a prospective pilot study. The main outcome of this study will be patient satisfaction with the medication and analgesia. Secondary outcomes will include level of sedation and analgesia, patient-reported post-procedural pain levels, and any reported adverse events.",[61],"All Adult Patients Undergoing an Otolaryngology Procedure With Inhaled Methoxyflurane as an Adjunct to Topical or Local Anesthesia","NOT_YET_RECRUITING","2025-05-26",{"date":65,"type":66},"2025-06-04","ACTUAL",{"date":68,"type":57},"2025-06-01",{"date":70,"type":57},"2027-06-01",{"name":5,"class":6}]