Recruiting

Lidocaine with OnabotulinumtoxinA

Sponsor:

Association of Migraine Disorders

Code:

NCT07571889

Conditions

Pain From onabotulinumtoxinA Injections

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

onabotulinumtoxinA prophylaxis with Lidocaine

OnabotulinumtoxinA prophylaxis with Saline

Study Details

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

Study ID

NCT07571889

Start date

Mar 3, 2026

Status verified date

May, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

18 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Lidocaine

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

placebo comparator: Saline

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

Interventions

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.

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.

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Frederick A Godley, MD

401-274-2300Rick@migrainedisorders.org

Leigh Serth

Leigh@migrainedisorders.org

Locations

University Otolaryngology

Recruiting

East Providence, Rhode Island, United States, 02905

Contacts

Frederick Godley III, MD

401-274-2300rickgodley1@gmail.com

More Information

Sponsor

Association of Migraine Disorders

Last update posted

May 6, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Association of Migraine Disorders on 2026-05-06.