Transnasal Sphenopalatine Ganglia Block for Management of Chronic Migraines in Pediatric Patients
Overview
- Phase
- Phase 2
- Intervention
- Headache Journal
- Conditions
- Migraine in Children
- Sponsor
- Washington University School of Medicine
- Locations
- 1
- Primary Endpoint
- Reduction in frequency of headache days: pre-treatment
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Minors with chronic migraines
Intervention: Headache Journal
Minors with chronic migraines
Intervention: Sphenopalatine Block
Minors with chronic migraines
Intervention: Tx360
Outcomes
Primary Outcomes
Reduction in frequency of headache days: pre-treatment
Time Frame: 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
Time Frame: Up to one year following consent
Weekly headache journal check in - 5 questions with y/n answers and free text entry
Secondary Outcomes
- Maximum headache severity: pre-treatment(up to 4 weeks following consent)
- Use of rescue medication: post-treatment(Up to one year following consent)
- Headache duration: pre-treatment(Up to 4 weeks following consent)
- Headache duration: post-treatment(Up to one year following consent)
- Maximum headache severity: post-treatment(up to one year following consent)
- Use of rescue medication: pre-treatment(Up to 4 weeks following consent)