Sphenopalatine Ganglion Block and Cold Induced Headaches

NCT06310200 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: IRB-2023-398
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cold Induced Headache; Brain Freeze; Cold Induced Cephalgia; Headache

Outcome Measures

Primary Outcomes (1)

• Does sphenopalatine ganglion (SPG) block prevent cold induced cephalgia

  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.

  5 months

Secondary Outcomes (3)

• Degree of pain

  5 months

• Duration of brain freeze

  5 months

• Time to onset of headache

  5 months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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.

Drug: Lidocaine Topical 4% Topical Solution

Placebo Arm

PLACEBO COMPARATOR

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.

Drug: Bitrex; Drug: normal saline

Interventions

Lidocaine Topical 4% Topical Solution DRUG

Intranasal administration

Intervention Arm

Bitrex DRUG

Bittering agent

Placebo Arm

normal saline DRUG

Placebo

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wright State University: lead

Study Sites (1)

Wright state emergency medicine offices

Dayton, Ohio, 45324, United States

Location

Related Publications (6)

• Lee JM, Shin TJ. Use of local anesthetics for dental treatment during pregnancy; safety for parturient. J Dent Anesth Pain Med. 2017 Jun;17(2):81-90. doi: 10.17245/jdapm.2017.17.2.81. Epub 2017 Jun 29.

  PMID: 28879335 BACKGROUND

• Hensel O, Burow P, Mages S, Wienke A, Kraya T, Zierz S. Increased Blood Flow Velocity in Middle Cerebral Artery and Headache Upon Ingestion of Ice Water. Front Neurol. 2019 Jun 28;10:677. doi: 10.3389/fneur.2019.00677. eCollection 2019.

  PMID: 31316454 BACKGROUND

• Binfalah M, Alghawi E, Shosha E, Alhilly A, Bakhiet M. Sphenopalatine Ganglion Block for the Treatment of Acute Migraine Headache. Pain Res Treat. 2018 May 7;2018:2516953. doi: 10.1155/2018/2516953. eCollection 2018.

  PMID: 29862074 BACKGROUND

• Bird N, MacGregor EA, Wilkinson MI. Ice cream headache--site, duration, and relationship to migraine. Headache. 1992 Jan;32(1):35-8. doi: 10.1111/j.1526-4610.1992.hed3201035.x.

  PMID: 1555929 BACKGROUND

• Morgan A, Romanello G. Use of the Sphenopalatine Ganglion Block to Treat Migraine Headaches in the Emergency Department. Cureus. 2022 Jan 19;14(1):e21428. doi: 10.7759/cureus.21428. eCollection 2022 Jan.

  PMID: 35103222 BACKGROUND

• Rocha-Romero A, Roychoudhury P, Cordero RB, Mendoza ML. [Self-applied sphenopalatine ganglion block for postdural puncture headache: four case reports]. Braz J Anesthesiol. 2020 Sep-Oct;70(5):561-564. doi: 10.1016/j.bjan.2020.07.002. Epub 2020 Sep 16.

  PMID: 33032805 BACKGROUND

MeSH Terms

Conditions

Headache

Interventions

Lidocaine; Solutions; denatonium; Saline Solution

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions

Study Officials

• Brian P Murray, DO

  Wright State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All besides PI
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: March 15, 2024
• Study Start: January 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)