Actively Recruiting
Topical Intranasal Anesthetic Block for Reducing the Pain of Botulinum Toxin Injections for Chronic Migraine
Led by Association of Migraine Disorders · Updated on 2026-05-06
18
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
A
Association of Migraine Disorders
Lead Sponsor
U
University Otolaryngology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Topical Intranasal Anesthetic Block for Reducing the Pain of Botulinum Toxin Injections for Chronic Migraine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Any gender
- Able to provide informed consent
- Meets clinical criteria for onabotulinumtoxinA treatment for chronic migraine, including having at least 2 days of disability per month due to facial or headache pain, or 8 or more headache days per month, or more than 15 headaches per month
- Scheduled to receive modified PREEMPT onabotulinumtoxinA injections at the clinical site
You will not qualify if you...
- Under 18 years of age
- Diagnosis of trigeminal neuralgia, cluster headache, or other primary headache disorders as the dominant diagnosis
- Unable to provide informed consent
- Known allergy or hypersensitivity to lidocaine or similar amide anesthetics
- Pregnancy or breastfeeding
- Unable to tolerate intranasal cotton pledgets
- Significant nasal problems at the cotton placement site
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Otolaryngology
East Providence, Rhode Island, United States, 02905
Actively Recruiting
Research Team
F
Frederick A Godley, MD
CONTACT
L
Leigh Serth
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here