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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

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Conditions

Pain From onabotulinumtoxinA Injections

Locations

University Otolaryngology

East Providence, Rhode Island 02905

United States