RecruitingNot ApplicableNCT07571889

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

Sponsor

Association of Migraine Disorders

Enrollment

18 participants

Start Date

Mar 3, 2026

Study Type

INTERVENTIONAL

Conditions

Pain From onabotulinumtoxinA Injections

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called OnabotulinumtoxinA prophylaxis with Saline and a procedure called onabotulinumtoxinA prophylaxis with Lidocaine for people with pain from onabotulinumtoxina injections. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREonabotulinumtoxinA 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.

PROCEDUREOnabotulinumtoxinA 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.

Locations(1)

University Otolaryngology

East Providence, Rhode Island, United States

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NCT07571889