RecruitingNot Applicable

Topical Intranasal Anesthetic Block for Reducing the Pain of Botulinum Toxin Injections for Chronic Migraine

United States18 participantsStarted 2026-03-03

Plain-language summary

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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged ≥18 years * Any gender * Able to provide informed consent * 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) * Scheduled for modified PREEMPT injections at the clinical site Exclusion Criteria: * Aged \< 18 years * Trigeminal neuralgia, cluster headache, or other primary headache disorders as dominant diagnosis * Not able to provide informed consent * Known allergy/hypersensitivity to lidocaine or amide anesthetics * Pregnancy/lactation * Inability to tolerate intranasal nasal cotton pledgets * Significant nasal pathology at placement site

What they're measuring

Overall patient-reported injection pain

Timeframe: Immediately before and immediately following the procedure at Study Visit 1 and again 12 weeks later at Study Visit 2.

Trial details

NCT IDNCT07571889

SponsorAssociation of Migraine Disorders

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01

Contact for this trial

Frederick A Godley, MD

401-274-2300 Rick@migrainedisorders.org

View on ClinicalTrials.gov More Pain From onabotulinumtoxinA Injections trials