30 Participants Needed

Lidocaine Spray for Brain Freeze

DE
Overseen ByDana E Schulz, DO
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Wright State University

Trial Summary

What is the purpose of this trial?

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

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.

What data supports the effectiveness of the drug Lidocaine Topical 4% Topical Solution for brain freeze?

Research shows that lidocaine, when used in different forms like intranasal or topical, can provide pain relief in conditions such as migraines and oral ulcers, suggesting it might help with brain freeze pain as well.12345

Is lidocaine spray safe for humans?

Lidocaine, when used topically, is generally considered safe but can cause serious side effects if absorbed in high amounts, such as lightheadedness, tingling, seizures, and heart or breathing problems. There have been reports of fatalities and serious side effects, especially in children, so it's important to use it carefully and under medical supervision.23678

How does the drug Lidocaine Topical 4% Spray differ from other treatments for brain freeze?

Lidocaine Topical 4% Spray is unique because it is a local anesthetic applied directly to the skin, which may help numb the area and prevent the sensation of brain freeze. Unlike other treatments that might not specifically target the sensation of brain freeze, this spray offers a direct and potentially immediate way to address the discomfort.2591011

Research Team

BP

Brian P Murray, DO

Principal Investigator

Wright State University

Eligibility Criteria

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

I am an EM resident or medical student at Wright State.
I have experienced a brain freeze before.
I am over 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

1 day
1 visit (in-person)

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.

1 day
1 visit (in-person)

Follow-up

Participants are monitored for any side effects and the degree of decreased pain/duration of brain freeze after the sphenopalatine ganglion block.

5 months

Treatment Details

Interventions

  • Lidocaine Topical 4% Topical Solution
Trial Overview The study tests if a sphenopalatine ganglion block using intranasal atomized lidocaine can prevent or reduce pain/duration of brain freezes compared to Bitrex and saline solutions.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intervention ArmExperimental Treatment1 Intervention
Subjects will receive 1 mL of 4% lidocaine (0.5mL in each nostril) administered by intranasal atomization or 0.9% normal saline administered by intranasal atomization.
Group II: Placebo ArmPlacebo Group2 Interventions
Subjects will receive normal saline placebo mixed with an edible bittering agent added to blind the participant from recognizing the taste of the lidocaine containing solution.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wright State University

Lead Sponsor

Trials
47
Recruited
55,300+

Findings from Research

In a study of 26 children and adolescents with status migraine, intravenous (IV) lidocaine was found to be a safe and effective treatment, with 90.3% of patients experiencing pain resolution.
On average, patients saw a significant reduction in pain scores within 16.3 hours, and the treatment was well-tolerated, with only one patient experiencing side effects that required interruption of the infusion.
Safety and Efficacy of IV Lidocaine in the Treatment of Children and Adolescents With Status Migraine.Ayulo, MA., Phillips, KE., Tripathi, S.[2019]
A case study of a 5-month-old infant revealed that seizures can occur due to toxicity from oral viscous lidocaine, highlighting a serious risk associated with its use in young children.
Despite previous reports of lidocaine toxicity, many healthcare providers remain unaware of its potential adverse effects, emphasizing the need for increased awareness and caution when prescribing topical lidocaine for pediatric patients.
Toxicity--seizures in an infant caused by (or related to) oral viscous lidocaine use.Smith, M., Wolfram, W., Rose, R.[2019]

References

BET 2: Does topical lidocaine improve oral intake in children with painful mouth ulcers? [2020]
Intranasal lidocaine to prevent headache following migraine aura. [2019]
Safety and Efficacy of IV Lidocaine in the Treatment of Children and Adolescents With Status Migraine. [2019]
Efficacy of topical 1% lidocaine in the symptomatic treatment of pain associated with oral mucosal trauma or minor oral aphthous ulcer: a randomized, double-blind, placebo-controlled, parallel-group, single-dose study. [2013]
Lidocaine ointment and spray. [2013]
Toxicity--seizures in an infant caused by (or related to) oral viscous lidocaine use. [2019]
Effect of 4% topical lidocaine applied to the face on the serum levels of lidocaine and its metabolite, monoethylglycinexylidide. [2016]
Neuropsychiatric side-effects of lidocaine: examples from the treatment of headache and a review. [2013]
Treatment of localized neuropathic pain of different etiologies with the 5% lidocaine medicated plaster - a case series. [2020]
10.Korea (South)pubmed.ncbi.nlm.nih.gov
Effect of fractional ablative carbon dioxide laser with lidocaine spray on skin flap survival in rats. [2020]
[Topical pharmacologic approach with 5% lidocaine medicated plaster in the treatment of localized neuropathic pain]. [2014]