Migraine in Children, Pain, Neuropathic
Conditions
Brief summary
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.
Interventions
OTHERHeadache Journal
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
DEVICETx360
Phase 2 of study providing medication using 0.3ml of 0.5% Bupivacaine per nares delivered intranasal via the Tx360 device
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label, pre/post-treatment pilot study
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in frequency of headache days: pre-treatment | Up to 4 weeks following consent | Weekly headache journal check in - 5 questions with y/n answers and free text entry |
| Reduction in frequency of headache days: post-treatment | Up to one year following consent | Weekly headache journal check in - 5 questions with y/n answers and free text entry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Headache duration: pre-treatment | Up to 4 weeks following consent | Participant records headache duration by documenting the start and end time of the headache |
| Headache duration: post-treatment | Up to one year following consent | Participant records headache duration by documenting the start and end time of the headache |
| Maximum headache severity: pre-treatment | up to 4 weeks following consent | Participant records headache intensity on headache journal. Scale is 0-10, with 0 being the least severity and 10 being the worst severity |
| Use of rescue medication: post-treatment | Up to one year following consent | Participant records use with a y/n answer and provides the name of the medication |
| Use of rescue medication: pre-treatment | Up to 4 weeks following consent | Participant records use with a y/n answer and provides the name of the medication |
| Maximum headache severity: post-treatment | up to one year following consent | Participant records headache intensity on headache journal. Scale is 0-10, with 0 being the least severity and 10 being the worst severity |
Countries
United States
Outcome results
None listed