Headache Clinical Trial
Official title:
Involvement of the Sphenopalatine Ganglion in 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
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Wright State University |
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03472872 -
A Comparative Efficacy Trial of IV Acetaminophen Versus IV Ketorolac for Emergency Department Treatment of Generalized Headache
|
Phase 4 | |
Withdrawn |
NCT05410366 -
Safe Harbors in Emergency Medicine, Specific Aim 3
|
||
Withdrawn |
NCT02866084 -
Neuromodulation Treatment of Vestibular Migraines
|
N/A | |
Active, not recruiting |
NCT03537573 -
Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Pain in Primary Care
|
N/A | |
Recruiting |
NCT05891808 -
miR-155 Expression in Episodic and Chronic Migraine
|
||
Not yet recruiting |
NCT04352218 -
Safety Profile of PETALO CVS in the Treatment of Non-thrombotic Internal Jugular Vein Stenosis and Chronic Headache
|
Phase 2 | |
Completed |
NCT02734992 -
Acceptance and Commitment Therapy vs Medical Treatment as Usual Wait-list Control for Primary Headache Sufferers
|
N/A | |
Completed |
NCT01153789 -
Study of Oculomotor Dysfunction Leading to Children Vertigo
|
N/A | |
Completed |
NCT01327118 -
Prostaglandin F2alpha in a Human Headache Model
|
N/A | |
Not yet recruiting |
NCT00969995 -
Identification of Inflammatory Markers in Migraine Patients
|
N/A | |
Not yet recruiting |
NCT00752921 -
Randomized Placebo Controlled Trial With Etoricoxib That is Taken to Prevent the Yom Kippur Headache
|
Phase 4 | |
Completed |
NCT00212810 -
Evaluation of the Effectiveness of Topiramate in Preventing the Transformation From Episodic Migraine to Chronic Daily Headache.
|
Phase 4 | |
Terminated |
NCT00291395 -
PGI2 Induced Headache and Cerebral Haemodynamics in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT00263094 -
An End to the Yom Kippur (and Ramadan) Headache
|
N/A | |
Completed |
NCT00135122 -
Prednisolone in the Treatment of Withdrawal Headache in Probable Medication Overuse Headache
|
Phase 3 | |
Completed |
NCT02475005 -
An Intervention to Improve Adolescent Headache Self-management
|
N/A | |
Completed |
NCT03163901 -
The Effect of OMT on Functional Outcomes and Anti-inflammatory Biomarkers in Mild to Moderate Traumatic Brain Injury
|
N/A | |
Completed |
NCT01664585 -
Exercise Training With Physically Active Lifestyle to Reduce Headache and Quality of Life
|
N/A | |
Completed |
NCT04632420 -
Evaluation of Headache and Childbirth in a Chronic Pain Population
|
||
Recruiting |
NCT05033613 -
Home Blood Pressure Monitoring Before and After COVID-19 Vaccination in Patients at High Risk of Cardiovascular Disease
|