Topical Intranasal Anesthetic Block for Reducing the Pain of Botulinum Toxin Injections for Chronic Migraine
Recruiting · NCT07571889 · Interventional (participants receive a specific treatment) · Lead sponsor: Association of Migraine Disorders
View the official record on ClinicalTrials.gov →Interventions studied
OnabotulinumtoxinA prophylaxis with SalineonabotulinumtoxinA prophylaxis with Lidocaine
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- University Otolaryngology - East Providence, Rhode Island, United States