Clinical trial NCT04466826: Transnasal Sphenopalatine Ganglia Block for Management of Chronic Migraines in Pediatric Patients
Official title: Transnasal Sphenopalatine Ganglia Block for Management of Chronic Migraines in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Migraine in Children
Pain, Neuropathic
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 0
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Open label, pre/post-treatment pilot study
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Reduction in frequency of headache days: pre-treatment
timeFrame: Up to 4 weeks following consent
measure: Reduction in frequency of headache days: post-treatment
timeFrame: Up to one year following consent
Secondary outcomes:
measure: Maximum headache severity: pre-treatment
timeFrame: up to 4 weeks following consent
measure: Maximum headache severity: post-treatment
timeFrame: up to one year following consent
measure: Headache duration: pre-treatment
timeFrame: Up to 4 weeks following consent
measure: Headache duration: post-treatment
timeFrame: Up to one year following consent
measure: Use of rescue medication: pre-treatment
timeFrame: Up to 4 weeks following consent
measure: Use of rescue medication: post-treatment
timeFrame: Up to one year following consent
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jacob AuBuchon, MD
role: PRINCIPAL_INVESTIGATOR
References:
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