SPG Block for Acute Pediatric Migraine

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

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.

Study Overview

• Status: Recruiting
• Conditions: Migraine in Children; Migraine in Adolescence; Sphenopalatine Neuralgia
• Intervention / Treatment: Drug: Lidocaine topical; Drug: Prochlorperazine Injection

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 Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Adam Sivitz, MD; Phone Number: 973 926 2484; Email: adam.sivitz@rwjbh.org

Study Locations

• United States
  • New Jersey
    • Newark, New Jersey, United States, 07112
      • Recruiting
      • Newark Beth Israel Medical Center
      • Contact: Adam Sivitz, MD; Phone Number: 973-926-2484; Email: adam.sivitz@rwjbh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPG block; 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	Drug: Lidocaine topical; Intranasal 2% lidocaine delivered directly to SPG
Active Comparator: Control; Delivered through IV access obtained in all patients.	Drug: Prochlorperazine Injection; intravenous prochlorperazine at 0.15mg/kg max 10 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to headache resolution	Time to headache resolution in emergency department	treatment start to patient reported resolution, up to 6 hours
ED Length of stay	treatment to discharge	Registration to discharge up to 6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
24 hr follow up	Presence of headache at 24 hrs	1 day
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
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.

Collaborators and Investigators

• Sponsor: Newark Beth Israel Medical Center
• Investigators: Principal Investigator: Adam Sivitz, MD, Newark Beth Israel Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2019
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: June 6, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (Actual): June 12, 2019

Study Record Updates

• Last Update Posted (Actual): November 17, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Peripheral Nervous System Diseases; Cranial Nerve Diseases; Headache Disorders, Primary; Headache Disorders; Facial Nerve Diseases; Neuralgia; Migraine Disorders; Facial Neuralgia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Dopamine Agents; Dopamine Antagonists; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Prochlorperazine
• Other Study ID Numbers: 2018.42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes