[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636915":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":59,"collaborators":61,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":26,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":26,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":26,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Association of Migraine Disorders","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lidocaine","EXPERIMENTAL","Intranasal 4% lidocaine: vial with 1ml solution with added flavor",[13],"Procedure: onabotulinumtoxinA prophylaxis with Lidocaine",{"label":15,"type":16,"description":17,"interventionNames":18},"Saline","PLACEBO_COMPARATOR","Vial with 1ml liquid containing 0.9% sodium chloride solution with identical flavor",[19],"Procedure: OnabotulinumtoxinA prophylaxis with Saline",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","onabotulinumtoxinA prophylaxis with Lidocaine","The onabotulinumtoxinA prophylaxis procedure is the modified PREEMPT protocol consisting of 56 injections; 200 Units. The solution from the vial (lidocaine) will be dripped onto 2 small pieces of cotton. One piece of cotton will be placed in the anterior portion of the nasal cavity on each side of the nose. The cotton will be removed after 5 minutes. The clinician will then perform the various series of injections while assessing pain of the injection site following each series of injections.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"OnabotulinumtoxinA prophylaxis with Saline","The onabotulinumtoxinA prophylaxis procedure is the modified PREEMPT protocol consisting of 56 injections; 200 Units. The solution from the vial (Saline) will be dripped onto 2 small pieces of cotton. One piece of cotton will be placed in the anterior portion of the nasal cavity on each side of the nose. The cotton will be removed after 5 minutes. The clinician will then perform the various series of injections while assessing pain of the injection site following each series of injections.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Frederick A Godley, MD","CONTACT","401-274-2300","Rick@migrainedisorders.org",{"name":38,"role":34,"phone":26,"phoneExt":26,"email":39},"Leigh Serth","Leigh@migrainedisorders.org",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"University Otolaryngology","RECRUITING","East Providence","Rhode Island","02905","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-71.37005,41.81371,{"lat":53,"lon":52},[56],{"name":57,"role":34,"phone":35,"phoneExt":26,"email":58},"Frederick Godley III, MD","rickgodley1@gmail.com",{"type":60,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[62],{"name":42,"class":63},"UNKNOWN","100636915","topical-intranasal-anesthetic-block-for-reducing-the-pain-of-botulinum-toxin-injections-for-chronic-migraine-100636915",false,"NCT07571889","Topical Intranasal Anesthetic Block for Reducing the Pain of Botulinum Toxin Injections for Chronic Migraine","Topical Intranasal Anesthetic Block for Reducing the Pain of Botulinum Toxin Injections for Chronic Migraine: A Randomized, Double-Blind, Placebo-Controlled Crossover Pilot Study","Inclusion Criteria:\n\n* Aged ≥18 years\n* Any gender\n* Able to provide informed consent\n* Meets clinical criteria for onabotulinumtoxinA for chronic migraine (minimum of 2 days of disability per month due to facial or headache pain, or 8 headache days per month, or more than 15 headaches per month)\n* Scheduled for modified PREEMPT injections at the clinical site\n\nExclusion Criteria:\n\n* Aged \\\u003C 18 years\n* Trigeminal neuralgia, cluster headache, or other primary headache disorders as dominant diagnosis\n* Not able to provide informed consent\n* Known allergy\u002Fhypersensitivity to lidocaine or amide anesthetics\n* Pregnancy\u002Flactation\n* Inability to tolerate intranasal nasal cotton pledgets\n* Significant nasal pathology at placement site","ALL","18 Years",{"count":74,"type":75},18,"ESTIMATED","INTERVENTIONAL",[78],"NA","People find the injections used in onabotulinumtoxinA (Botox®) uncomfortable. This study will test whether putting a small piece of cotton soaked with 4% lidocaine (a numbing medicine) inside the front of each nostril for 5 minutes before the injections reduces injection pain compared with cotton soaked in saline (salt water).",[81],"Pain From onabotulinumtoxinA Injections","2026-05-04",{"date":84,"type":85},"2026-05-06","ACTUAL",{"date":87,"type":85},"2026-03-03",{"date":89,"type":75},"2027-01",{"name":5,"class":6},1]