SPG Block for Acute Pediatric Migraine

Phase 3

• Conditions: Sphenopalatine Neuralgia; Migraine in Children; Migraine in Adolescence
• Interventions: Drug: Prochlorperazine Injection; Drug: Lidocaine topical

• Registration Number: NCT03984045
• Lead Sponsor: Newark Beth Israel Medical Center

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2019-06-06
• Study First Submitted: 2019-06-06
• Study First Submitted QC: 2019-06-11
• Study First Posted: 2019-06-12
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-16
• Last Update Posted: 2021-11-17
• Primary Completion: 2022-06-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Prochlorperazine Injection	Delivered through IV access obtained in all patients.
SPG block	Lidocaine topical	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

Primary Outcome Measures

Name	Time	Method
Time to headache resolution	treatment start to patient reported resolution, up to 6 hours	Time to headache resolution in emergency department
ED Length of stay	Registration to discharge up to 6 hours	treatment to discharge

Secondary Outcome Measures

Name	Time	Method
24 hr follow up	1 day	Presence of headache at 24 hrs
Number of participants with treatment induced side effects	1 day	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.
Patient satisfaction: Rated on a Likert 100 millimeter scale	Within 6 hours from ED registration	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)
Determine adequacy of blinding	Asked at time of patient discharge from the emergency department or at 1 hr.	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.

Trial Locations

Locations (1)

Newark Beth Israel Medical Center; 🇺🇸 Newark, New Jersey, United States