Topical Intranasal Anesthetic Block for Reducing the Pain of Botulinum Toxin Injections for Chronic Migraine

Topical Intranasal Anesthetic Block for Reducing the Pain of Botulinum Toxin Injections for Chronic Migraine: A Randomized, Double-Blind, Placebo-Controlled Crossover Pilot Study

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).

Study Overview

• Status: Recruiting
• Conditions: Pain From onabotulinumtoxinA Injections
• Intervention / Treatment: Procedure: onabotulinumtoxinA prophylaxis with Lidocaine; Procedure: OnabotulinumtoxinA prophylaxis with Saline

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frederick A Godley, MD; Phone Number: 401-274-2300; Email: Rick@migrainedisorders.org
• Study Contact Backup: Name: Leigh Serth; Email: Leigh@migrainedisorders.org

Study Locations

• United States
  • Rhode Island
    • East Providence, Rhode Island, United States, 02905
      • Recruiting
      • University Otolaryngology
      • Contact: Frederick Godley III, MD; Phone Number: 401-274-2300; Email: rickgodley1@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine; Intranasal 4% lidocaine: vial with 1ml solution with added flavor	Procedure: onabotulinumtoxinA prophylaxis with Lidocaine; The 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.
Placebo Comparator: Saline; Vial with 1ml liquid containing 0.9% sodium chloride solution with identical flavor	Procedure: OnabotulinumtoxinA prophylaxis with Saline; The 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall patient-reported injection pain	Overall patient-reported injection pain [0 (no pain) -10 (worse pain possible) Likert/Numeric Rating Scale] between 4% lidocaine versus 0.9% saline.	Immediately before and immediately following the procedure at Study Visit 1 and again 12 weeks later at Study Visit 2.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported injection pain at each region	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)	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.

Collaborators and Investigators

• Sponsor: Association of Migraine Disorders
• Collaborators: University Otolaryngology

Publications and helpful links

General Publications

• Aurora SK, Winner P, Freeman MC, Spierings EL, Heiring JO, DeGryse RE, VanDenburgh AM, Nolan ME, Turkel CC. OnabotulinumtoxinA for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache. 2011 Oct;51(9):1358-73. doi: 10.1111/j.1526-4610.2011.01990.x. Epub 2011 Aug 29.
• Blumenfeld A, Silberstein SD, Dodick DW, Aurora SK, Turkel CC, Binder WJ. Method of injection of onabotulinumtoxinA for chronic migraine: a safe, well-tolerated, and effective treatment paradigm based on the PREEMPT clinical program. Headache. 2010 Oct;50(9):1406-18. doi: 10.1111/j.1526-4610.2010.01766.x.
• Comite S, Greene A, Cieszynski SA, Zaroovabeli P, Marks K. Minimizing discomfort during the injection of Radiesse with the use of either local anesthetic or ice. Dermatol Online J. 2007 Jul 13;13(3):5.
• Hamilton HK, Arndt KA. Techniques for minimizing pain with injections. J Am Acad Dermatol. 2013 Sep;69(3):e117. doi: 10.1016/j.jaad.2013.05.024. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Lidocaine; Sodium Chloride
• Other Study ID Numbers: Lidocaine Block Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a pilot study of patients seen in a single clinic.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No