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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University Otolaryngology
East Providence, Rhode Island 02905
Contact:
Frederick Godley III, MD
401-274-2300
rickgodley1@gmail.com

More Details

Status
Recruiting
Sponsor
Association of Migraine Disorders

Study Contact

Frederick A Godley, MD
401-274-2300
Rick@migrainedisorders.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.