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

RecruitingNot applicableNCT07571889
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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).

Study details

Official title
Topical Intranasal Anesthetic Block for Reducing the Pain of Botulinum Toxin Injections for Chronic Migraine: A Randomized, Double-Blind, Placebo-Controlled Crossover Pilot Study
Conditions
  • Pain From onabotulinumtoxinA Injections
Interventions
  • Procedure: onabotulinumtoxinA prophylaxis with Lidocaine
  • Procedure: OnabotulinumtoxinA prophylaxis with Saline
Sponsor
Association of Migraine Disorders
Collaborators
University Otolaryngology
Start date
2026-03-03
Primary completion
2027-01
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07571889