Topical Intranasal Anesthetic Block for Reducing the Pain of Botulinum Toxin Injections for Chronic Migraine
4. maj 2026 opdateret af: Association of Migraine Disorders
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).
Studieoversigt
Status
Rekruttering
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
18
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Frederick A Godley, MD
- Telefonnummer: 401-274-2300
- E-mail: Rick@migrainedisorders.org
Undersøgelse Kontakt Backup
- Navn: Leigh Serth
- E-mail: Leigh@migrainedisorders.org
Studiesteder
-
-
Rhode Island
-
East Providence, Rhode Island, Forenede Stater, 02905
- Rekruttering
- University Otolaryngology
-
Kontakt:
- Frederick Godley III, MD
- Telefonnummer: 401-274-2300
- E-mail: rickgodley1@gmail.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Lidocaine
Intranasal 4% lidocaine: vial with 1ml solution with added flavor
|
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 komparator: Saline
Vial with 1ml liquid containing 0.9% sodium chloride solution with identical flavor
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall patient-reported injection pain
Tidsramme: Immediately before and immediately following the procedure at Study Visit 1 and again 12 weeks later at Study Visit 2.
|
Overall patient-reported injection pain [0 (no pain) -10 (worse pain possible) Likert/Numeric Rating Scale] between 4% lidocaine versus 0.9% saline.
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Immediately before and immediately following the procedure at Study Visit 1 and again 12 weeks later at Study Visit 2.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient-reported injection pain at each region
Tidsramme: 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.
|
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:
|
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.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
3. marts 2026
Primær færdiggørelse (Anslået)
1. januar 2027
Studieafslutning (Anslået)
1. januar 2027
Datoer for studieregistrering
Først indsendt
21. november 2025
Først indsendt, der opfyldte QC-kriterier
4. maj 2026
Først opslået (Faktiske)
6. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Lidocaine Block Study
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
This is a pilot study of patients seen in a single clinic.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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