Nasal lidocaine to reduce pain from Botox injections for chronic migraine
Official title: Topical Intranasal Anesthetic Block for Reducing the Pain of Botulinum Toxin Injections for Chronic Migraine: A Randomized, Double-Blind, Placebo-Controlled Crossover Pilot Study
Run by Association of Migraine Disorders · NCT07571889 · Data updated 2026-11-12
This test will see if placing small cotton pieces soaked in 4% lidocaine inside each nostril for five minutes before onabotulinumtoxinA (Botox) injections lowers injection pain for adults getting Botox for chronic migraine.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 18 (estimated) |
| Sponsor | Association of Migraine Disorders Academic / other |
| Locations | 1 site (East Providence, Rhode Island) |
| Status | Recruiting |
| Started | March 3, 2026 |
| Main results expected | January 2027 |
| Study ends | January 2027 |
| Registry record updated | May 6, 2026 |
| Trial ID | NCT07571889 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) scheduled for modified PREEMPT onabotulinumtoxinA for chronic migraine who can give informed consent, are not pregnant, are not allergic to lidocaine, and can tolerate intranasal cotton pledgets.
✕Probably not a fit
People who are allergic to lidocaine or other amide anesthetics, pregnant or breastfeeding, unable to tolerate intranasal pledgets, or with significant nasal pathology or a different dominant primary headache disorder are unlikely to be eligible or to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares intranasal 4% lidocaine–soaked cotton pledgets versus saline-soaked pledgets placed in the anterior nostrils for five minutes prior to standardized modified PREEMPT onabotulinumtoxinA injections. Adults who meet clinical criteria for onabotulinumtoxinA prophylaxis for chronic migraine and can tolerate intranasal cotton pledgets are eligible. Pain experienced during the injections will be recorded and compared between the lidocaine and saline groups. Key exclusions include lidocaine allergy, pregnancy or lactation, significant nasal pathology, and other dominant primary headache disorders.
Why it matters
Potential benefit: If effective, this simple, low-cost approach could reduce the pain of Botox injections and improve patient comfort during prophylactic treatment.
How similar studies have gone: Applying topical intranasal anesthetic specifically to reduce pain from onabotulinumtoxinA injections is relatively novel and there is limited published data on this exact technique.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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University Otolaryngology
East Providence, Rhode Island, United States Recruiting
Study contacts
- Study coordinator: Frederick A Godley, MD
- Email: Rick@migrainedisorders.org
- Phone: 401-274-2300
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.