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

The Washington University

Status and phase: Withdrawn; Phase 2

Conditions: Pain, Neuropathic; Migraine in Children

Treatments: Drug: Sphenopalatine Block; Other: Headache Journal; Device: Tx360

Study type: Interventional

Funder types: Other

Identifiers

NCT04466826

202006033

Details and patient eligibility

About

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.

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Minors with chronic migraines

Experimental group

Treatment:

Device: Tx360

Other: Headache Journal

Drug: Sphenopalatine Block