NCT07571889NARecruiting
Topical Intranasal Anesthetic Block for Reducing the Pain of Botulinum Toxin Injections for Chronic Migraine
Association of Migraine Disorders
Start Date
3/3/2026
Completion Date
1/1/2027
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).
Eligibility Criteria
Age Range: 18 years to No maximum
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
Interventions
PROCEDURE
onabotulinumtoxinA prophylaxis with Lidocaine
PROCEDURE
OnabotulinumtoxinA prophylaxis with Saline
Conditions
Pain From onabotulinumtoxinA Injections
Locations
University Otolaryngology
East Providence, Rhode Island 02905
United States