SPG Block for Acute Pediatric Migraine

Newark Beth Israel Medical Center

Status and phase: Unknown; Phase 3

Conditions: Migraine in Adolescence; Sphenopalatine Neuralgia; Migraine in Children

Treatments: Drug: Prochlorperazine Injection; Drug: Lidocaine topical

Study type: Interventional

Funder types: Other

Identifiers

NCT03984045

2018.42

Details and patient eligibility

About

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.

Full 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

Enrollment: 72 estimated patients

Sex: All

Ages: 10 to 20 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups

SPG block

Experimental group

Description:

SPG block performed by using qtip applicator soaked in 2% lidocaine and placed posteriorly into nasal cavity where it dwells for up to 30 min

Treatment:

Drug: Lidocaine topical

Control

Active Comparator group

Description:

Delivered through IV access obtained in all patients.

Treatment:

Drug: Prochlorperazine Injection