Transnasal Sphenopalatine Ganglia Block for Management of Chronic Migraines in Pediatric Patients

Study Overview
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Brief Summary
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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.

Official Title
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Transnasal Sphenopalatine Ganglia Block for Management of Chronic Migraines in Pediatric Patients

Conditions
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Migraine in Children, Pain, Neuropathic

Intervention / Treatment
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* Other: Headache Journal
* Drug: Sphenopalatine Block
* Device: Tx360


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children ages 8 to 17 years old Meet the criteria for chronic migraines Have remained stable on their current headache medication for a minimum of 4 weeks. Able to provide informed consent from parent or legal guardian Able to provide assent if subject is a minor of appropriate age Exclusion Criteria: Allergy to local anesthetic Developmental delay (e.g. non-verbal) Inability to use numeric pain scale Inability to perform or tolerate transnasal procedure Substance abuse disorders Known pregnancy

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Interventional Model Description: Open label, pre/post-treatment pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minors with chronic migraines<br> | Other: Headache Journal<br>* Phase 1 of study to determine a baseline for headache frequency, headache intensity and medication usage patterns<br>Drug: Sphenopalatine Block<br>* Phase 2 of study providing medication using 0.3ml of 0.5% Bupivacaine per nares delivered intranasal via the Tx360 device<br>Device: Tx360<br>* Phase 2 of study providing medication using 0.3ml of 0.5% Bupivacaine per nares delivered intranasal via the Tx360 device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in frequency of headache days: pre-treatment | Weekly headache journal check in - 5 questions with y/n answers and free text entry | 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 | Up to one year following consent | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | up to one year following consent | 
| Headache duration: pre-treatment | Participant records headache duration by documenting the start and end time of the headache | Up to 4 weeks following consent | 
| Headache duration: post-treatment | Participant records headache duration by documenting the start and end time of the headache | 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 | Up to 4 weeks following consent | 
| Use of rescue medication: post-treatment | Participant records use with a y/n answer and provides the name of the medication | Up to one year following consent |