Single-center, open-label, pre-post treatment pilot study to evaluate the safety and effectiveness of sphenopalatine ganglia blocks for the treatment of chronic migraine in the pediatric population. 50 children with a diagnosis of chronic migraines will undergo a series of three transnasal sphenopalatine ganglia blocks to measure their effect on headache frequency, headache intensity, headache duration, and use of headache medication.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Phase 1 of study to determine a baseline for headache frequency, headache intensity and medication usage patterns
Phase 2 of study providing medication using 0.3ml of 0.5% Bupivacaine per nares delivered intranasal via the Tx360 device
Phase 2 of study providing medication using 0.3ml of 0.5% Bupivacaine per nares delivered intranasal via the Tx360 device
St. Louis Children's Hospital
St Louis, Missouri, United States
Reduction in frequency of headache days: pre-treatment
Weekly headache journal check in - 5 questions with y/n answers and free text entry
Time frame: Up to 4 weeks following consent
Reduction in frequency of headache days: post-treatment
Weekly headache journal check in - 5 questions with y/n answers and free text entry
Time frame: Up to one year following consent
Maximum headache severity: pre-treatment
Participant records headache intensity on headache journal. Scale is 0-10, with 0 being the least severity and 10 being the worst severity
Time frame: up to 4 weeks following consent
Maximum headache severity: post-treatment
Participant records headache intensity on headache journal. Scale is 0-10, with 0 being the least severity and 10 being the worst severity
Time frame: up to one year following consent
Headache duration: pre-treatment
Participant records headache duration by documenting the start and end time of the headache
Time frame: Up to 4 weeks following consent
Headache duration: post-treatment
Participant records headache duration by documenting the start and end time of the headache
Time frame: Up to one year following consent
Use of rescue medication: pre-treatment
Participant records use with a y/n answer and provides the name of the medication
Time frame: Up to 4 weeks following consent
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Use of rescue medication: post-treatment
Participant records use with a y/n answer and provides the name of the medication
Time frame: Up to one year following consent