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

Phase 2

Withdrawn

• Conditions: Pain, Neuropathic; Migraine in Children
• Interventions: Other: Headache Journal; Drug: Sphenopalatine Block; Device: Tx360

• Registration Number: NCT04466826
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-07-06
• Study First Submitted QC: 2020-07-06
• Study First Posted: 2020-07-10
• Study Start: 2021-01-02
• Status Verified: 2021-02
• Primary Completion: 2021-02-05
• Study Completion: 2021-02-05
• Last Update Submitted: 2021-02-05
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Minors with chronic migraines	Tx360	-
Minors with chronic migraines	Sphenopalatine Block	-
Minors with chronic migraines	Headache Journal	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

St. Louis Children's Hospital; 🇺🇸 Saint Louis, Missouri, United States