Sphenopalatine Ganglion Block and Cold Induced Headaches

Headache Clinical Trial

Official title:

Involvement of the Sphenopalatine Ganglion in Cold Induced Headaches

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06310200
• Other study ID #: IRB-2023-398
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 1, 2024
• Est. completion date: July 1, 2024

Study information

• Verified date: March 2024
• Source: Wright State University
• Contact: Dana E Schulz, DO
• Phone: 6317071796
• Email: dana.schulz[@]wright.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Headache

Intervention

Drug:
• Lidocaine Topical 4% Topical Solution
Intranasal administration
• Bitrex
Bittering agent
• normal saline
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wright State University

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Degree of pain	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.	5 months
Secondary	Duration of brain freeze	Determine duration of brain freeze after SPG block; measured in minutes and seconds.	5 months
Secondary	Time to onset of headache	Determined in minutes and seconds.	5 months