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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether numbing medicine placed inside the nose can reduce pain from Botox injections for chronic migraine. Adults scheduled for these injections will have cotton soaked in either 4% lidocaine (numbing medicine) or saline (salt water) placed in the front of each nostril for 5 minutes before the injections.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older, of any gender.
  • Able to understand the study and agree to take part.
  • Meet the rules for Botox treatment for chronic migraine: face or head pain that limits daily activities at least 2 days a month, 8 headache days a month, or more than 15 headaches a month.
  • Scheduled for a Botox injection plan called modified PREEMPT at the study clinic.

Who can't join

  • Under age 18.
  • Have another main headache or face pain condition, such as trigeminal neuralgia (nerve pain in the face) or cluster headaches.
  • Unable to understand the study and agree to take part.
  • Have a known allergy or sensitivity to lidocaine or similar numbing medicines called amide anesthetics.
  • Pregnant or breastfeeding.
  • Unable to tolerate small pieces of cotton inside the nose.
  • Have a major problem inside the nose where the cotton would be placed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

RI