SPG Block for Acute Pediatric Migraine

Migraine in Children Clinical Trial

Official title:

Sphenopalatine Ganglion Block for Treating Acute Frontal Migraine Headache in Pediatric Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03984045
• Other study ID #: 2018.42
• Status: Recruiting
• Phase: Phase 3
• Start date: June 6, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: November 2021
• Source: Newark Beth Israel Medical Center
• Contact: Adam Sivitz, MD
• Phone: 973 926 2484
• Email: adam.sivitz[@]rwjbh.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized double blind trial comparing an intranasal sphenopalatine block with 2% lidocaine to intravenous (0.15 mg/kg, max 10mg) prochlorperazine in patients greater than 10 years of age presenting to a pediatric emergency department with an acute frontal migraine headache.

Description:

This is a randomized double blind trial comparing an intranasal sphenopalatine block with 2% lidocaine to intravenous (0.15 mg/kg, max 10mg) prochlorperazine in patients greater than 10 years of age presenting to a pediatric emergency department with an acute frontal migraine headache. Excluded populations include those with sickle cell, concern for CNS infection

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 20 Years

Eligibility

Inclusion Criteria:

• Frontal migraine headache

Exclusion Criteria:

• Non-english speaking

• Known pregnancy

• Sickle cell hemaglobinopathy

• Concern for CNS infection

• Acute febrile illness

• non-frontal headaches

• Concern for increased intracranial pressure

Related Conditions & MeSH terms

• Facial Neuralgia
• Migraine Disorders
• Migraine in Adolescence
• Migraine in Children
• Neuralgia
• Sphenopalatine Neuralgia

Intervention

Drug:
• Lidocaine topical
Intranasal 2% lidocaine delivered directly to SPG
• Prochlorperazine Injection
intravenous prochlorperazine at 0.15mg/kg max 10 mg

Locations

Country	Name	City	State
United States	Newark Beth Israel Medical Center	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Newark Beth Israel Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to headache resolution	Time to headache resolution in emergency department	treatment start to patient reported resolution, up to 6 hours
Primary	ED Length of stay	treatment to discharge	Registration to discharge up to 6 hours
Secondary	Patient satisfaction: Rated on a Likert 100 millimeter scale	Patient satisfaction as determined by whether they would absolutely want treatment again (score=100), or would absolutely prefer another method (score = 0), or something in between (any mark along the 100 millimeter line)	Within 6 hours from ED registration
Secondary	24 hr follow up	Presence of headache at 24 hrs	1 day
Secondary	Number of participants with treatment induced side effects	Recording appearance of any side effects in ED or within 24 hr follow up, such as nausea, vomiting, neck stiffness, seizure, or prolonged (greater than 6hrs) numbness.	1 day
Secondary	Determine adequacy of blinding	Determine whether treating physicians or patients can guess treatment arm (IN or IV arm) by simply asking the blinded patient and clinician which method they think the patient underwent. Measured by guessing one or the other arm.	Asked at time of patient discharge from the emergency department or at 1 hr.