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Active, Not Recruiting

NCT Number: NCT06310200

Sphenopalatine Ganglion Block and Cold Induced Headaches

The primary objective of this study is to determine if a sphenopalatine ganglion (SPG) block, performed through intranasal atomization of 4% lidocaine, is able to prevent cold induced cephalgia ("Brain Freeze"). Secondary objectives will be to determine the degree of decreased pain/duration of brain freeze after sphenopalatine ganglion block

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cold Induced Headache Brain Freeze Cold Induced Cephalgia Headache Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Wright state emergency medicine offices

Dayton, Ohio, 45324, United States

About this study

This study will be performed in two phases. The first phase will include a pre-medicated phase where the subjects will be required to rapidly drink up to ½ of a 32 fluid oz icecold slushy to induce a brain freeze. The flavor will be chosen by the participants. The time to onset, intensity, location, and duration of the headache will be recorded. The second phase will commence when the subjects have returned to their normal pain free state, a minimum of 10 minutes has passed since the resolution of the first cold headache, and they feel ready to move to the next phase. The time from complete resolution of the brain freeze to the start of the second phase will be recorded. Any subject that wishes to drop out from the study at this time is free to do so. They may keep their drink and finish it at a more leisurely pace should they choose.

Then the subjects will receive either 1 mL of 4% lidocaine (0.5mL in each nostril) administered by intranasal atomization or 0.9% normal saline administered by intranasal atomization. The normal saline placebo will be mixed with an edible bittering agent added to blind the participant from recognizing the taste of the lidocaine containing solution.

Only participants that experienced a brain freeze in the first phase will be able to move onto the second phase. Each participant will then rapidly drink up to ½ of a 32 fluid oz ice-cold slushy to induce a brain freeze. The time to onset, intensity, location, and duration of the headache will be recorded.

All pain scores will be recorded using a visual analog scale from 0-100 where 0 is no pain and 100 is the worst pain imaginable. We will also record any side effects that the subjects may experience during or shortly after the procedure.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Wright State University Emergency Medicine (EM) resident physicians and Wright State Boonshoft School of Medicine medical students
  • Over the age of 18 years
  • Has gotten at least one brain freeze in their life

Exclusion criteria

  • Individuals who have never gotten a brain freeze
  • Anyone who has had any sort of prior trauma to their oro- or nasopharynx or surgery on their oro- or nasopharynx, not to include dental surgery.
  • Pregnant patients
  • History of allergy to local anesthetic

Treatment and study plan

Lidocaine Topical 4% Topical Solution

Drug

Intranasal administration

Bitrex

Drug

Bittering agent

normal saline

Drug

Placebo

Primary outcomes

  1. Does sphenopalatine ganglion (SPG) block prevent cold induced cephalgia

    Time frame: 5 months

    The primary objective of this study is to determine if a sphenopalatine ganglion block, performed through intranasal atomization of 4% lidocaine, is able to prevent brain freeze. This study will be performed in two phases. The first phase will include a pre-medicated phase where the subjects will be required to rapidly drink up to ½ of a 32 fluid oz icecold slushy to induce a brain freeze. The second phase will commence when the subjects have returned to their normal pain free state, a minimum of 10 minutes has passed since the resolution of the first cold headache. The time from complete resolution of the brain freeze to the start of the second phase will be recorded. Each participant will then rapidly drink up to ½ of a 32 fluid oz ice-cold slushy to induce a brain freeze. The presence or absence of a cold-induced headache will be recorded for each phase.

Secondary outcomes

  1. Degree of pain

    Time frame: 5 months

    Determine the degree of decreased pain after SPG block. All pain scores will be recorded using a visual analog scale from 0-100 where 0 is no pain and 100 is the worst pain imaginable.

  2. Duration of brain freeze

    Time frame: 5 months

    Determine duration of brain freeze after SPG block; measured in minutes and seconds.

  3. Time to onset of headache

    Time frame: 5 months

    Determined in minutes and seconds.

Sponsors and collaborators

Lead sponsor

Wright State University

Other

Registry information

Official study title

Involvement of the Sphenopalatine Ganglion in Cold Induced Headaches

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 15, 2024
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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