Lidocaine Spray for Brain Freeze
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a nasal spray with lidocaine (a local anesthetic) can prevent brain freeze, the headache that occurs when eating something cold. Researchers aim to determine if this spray can either stop the pain or shorten its duration. Participants will receive either the lidocaine spray or a placebo (a fake treatment) for comparison. The trial seeks individuals who have experienced brain freeze and are medical students or residents at Wright State University. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative treatment.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research shows that using lidocaine as a skin treatment is usually safe. Some studies have found it helpful for relieving headaches. However, excessive lidocaine in the body can cause serious side effects like dizziness or tingling sensations.
In other treatments, a stronger 10% lidocaine spray for the nose proved effective, suggesting that the 4% solution in this trial might also be safe and effective. The key to safety and effectiveness lies in using the correct amount and method. The researchers have safety measures in place to manage any unexpected reactions.
Participants should discuss any concerns with the trial team to fully understand the possible risks and benefits.12345Why do researchers think this study treatment might be promising?
Unlike typical remedies for brain freeze, which usually involve waiting it out or using general warming techniques, this new lidocaine spray treatment acts directly on the nerves responsible for the pain. Researchers are excited because lidocaine is a topical anesthetic that temporarily numbs the area, offering quick relief. This treatment is administered through intranasal atomization, directly targeting the nerves in the head, which is a novel delivery method compared to traditional oral or external cooling methods. This precise and fast-acting approach could revolutionize how we handle the sudden, sharp headaches caused by eating or drinking something cold.
What evidence suggests that lidocaine spray might be an effective treatment for brain freeze?
Research has shown that lidocaine nasal spray can help relieve headaches, including migraines. One study found that a 10% lidocaine nasal spray eased headaches, though there was a reasonable chance of recurrence. Another study found that intravenous lidocaine effectively treated migraines in children and teenagers, with over 90% experiencing relief. Although strong evidence does not specifically support lidocaine's effect on brain freeze, its success with similar headaches suggests potential efficacy. This trial will test a 4% lidocaine nasal spray to determine if it can reduce brain freeze symptoms by blocking a nerve bundle linked to headache pain.12367
Who Is on the Research Team?
Brian P Murray, DO
Principal Investigator
Wright State University
Are You a Good Fit for This Trial?
This trial is for Wright State University Emergency Medicine residents and medical students over 18 who've had at least one brain freeze. It's not specified who can't join, but typically those with allergies or conditions affected by the treatments would be excluded.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-medicated Phase
Participants 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 are recorded.
Treatment Phase
Participants receive either 1 mL of 4% lidocaine or 0.9% normal saline administered by intranasal atomization. They 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 are recorded.
Follow-up
Participants are monitored for any side effects and the degree of decreased pain/duration of brain freeze after the sphenopalatine ganglion block.
What Are the Treatments Tested in This Trial?
Interventions
- Lidocaine Topical 4% Topical Solution
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wright State University
Lead Sponsor