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

NCT07571889 | Recruiting

• 1 other identifier: Lidocaine Block Study
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Pain From onabotulinumtoxinA Injections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient-reported injection pain at each region

  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.

Study Arms (2)

Lidocaine

EXPERIMENTAL

Intranasal 4% lidocaine: vial with 1ml solution with added flavor

Procedure: onabotulinumtoxinA prophylaxis with Lidocaine

Saline

PLACEBO COMPARATOR

Vial with 1ml liquid containing 0.9% sodium chloride solution with identical flavor

Procedure: OnabotulinumtoxinA prophylaxis with Saline

Interventions

onabotulinumtoxinA prophylaxis with Lidocaine PROCEDURE

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.

Lidocaine

OnabotulinumtoxinA prophylaxis with Saline PROCEDURE

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.

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Association of Migraine Disorders: lead
• University Otolaryngology: collaborator

Study Sites (1)

University Otolaryngology

East Providence, Rhode Island, 02905, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 21883197 BACKGROUND

• 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.

  PMID: 20958294 BACKGROUND

• 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.

  PMID: 18328199 BACKGROUND

• 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.

  PMID: 23957989 BACKGROUND

MeSH Terms

Interventions

Lidocaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Frederick A Godley, MD

CONTACT

401-274-2300; Rick@migrainedisorders.org

Leigh Serth

CONTACT

Leigh@migrainedisorders.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: May 6, 2026
• Study Start: March 3, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)