University Otolaryngology
East Providence, Rhode Island, 02905, United States
Location status: Recruiting
Recruiting
NCT Number: NCT07571889
Topical Intranasal Anesthetic Block for Reducing the Pain of Botulinum Toxin Injections for Chronic Migraine
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).
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
onabotulinumtoxinA prophylaxis with Lidocaine
ProcedureThe onabotulinumtoxinA prophylaxis procedure is the modified PREEMPT protocol consisting of 56 injections; 200 Units. The solution from the vial (lidocaine) will be dripped onto 2 small pieces of cotton. One piece of cotton will be placed in the anterior portion of the nasal cavity on each side of the nose. The cotton will be removed after 5 minutes. The clinician will then perform the various series of injections while assessing pain of the injection site following each series of injections.
OnabotulinumtoxinA prophylaxis with Saline
ProcedureThe onabotulinumtoxinA prophylaxis procedure is the modified PREEMPT protocol consisting of 56 injections; 200 Units. The solution from the vial (Saline) will be dripped onto 2 small pieces of cotton. One piece of cotton will be placed in the anterior portion of the nasal cavity on each side of the nose. The cotton will be removed after 5 minutes. The clinician will then perform the various series of injections while assessing pain of the injection site following each series of injections.
Primary outcomes
-
Overall patient-reported injection pain
Time frame: Immediately before and immediately following the procedure at Study Visit 1 and again 12 weeks later at Study Visit 2.
Overall patient-reported injection pain [0 (no pain) -10 (worse pain possible) Likert/Numeric Rating Scale] between 4% lidocaine versus 0.9% saline.
Secondary outcomes
-
Patient-reported injection pain at each region
Time frame: At Study Visit 1 and 12 weeks later at Study Visit 2. Ratings will occur within 1 minute of injection for each injection region during the procedure.
Comparison of patient-reported injection pain [0 (no pain) -10 (worse pain possible) Likert/Numeric Rating Scale] between regions by treatment. Facial anatomical regions include:
- Forehead/glabellar (frontalis + corrugator/procerus)
- Right temple (temporalis)
- Left temple (temporalis)
- Posterior scalp/neck (occipitalis, cervical paraspinals, trapezius combined)
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Association of Migraine Disorders
Other
Collaborators
- University Otolaryngology
Registry information
Official study 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
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- May 6, 2026
- Registry last updated
- May 6, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.