Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310200
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2023-10-12
Brief Title:
Sphenopalatine Ganglion Block and Cold Induced Headaches
Sponsor:
Wright State University
Organization:
Wright State University
Study Overview
Official Title:
Involvement of the Sphenopalatine Ganglion in Cold Induced Headaches
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 painduration of brain freeze after sphenopalatine ganglion block
Detailed 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 05mL in each nostril administered by intranasal atomization or 09 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
Then the subjects will receive either 1 mL of 4 lidocaine 05mL in each nostril administered by intranasal atomization or 09 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None