SPG Block for Acute Pediatric Migraine

NCT03984045 | Unknown Phase 3 FDA Drug

• 1 other identifier: 2018.42
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine in Children; Sphenopalatine Neuralgia; Migraine in Adolescence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Patient satisfaction: Rated on a Likert 100 millimeter scale

  Within 6 hours from ED registration

• 24 hr follow up

  1 day

• Number of participants with treatment induced side effects

  1 day

• Determine adequacy of blinding

  Asked at time of patient discharge from the emergency department or at 1 hr.

Study Arms (2)

SPG block

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

Delivered through IV access obtained in all patients.

Drug: Prochlorperazine Injection

Interventions

Lidocaine topical DRUG

Intranasal 2% lidocaine delivered directly to SPG

SPG block

Prochlorperazine Injection DRUG

intravenous prochlorperazine at 0.15mg/kg max 10 mg

Control

Eligibility Criteria

• Age: 10 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- Frontal migraine headache

You may not qualify if:

• Non-english speaking
• Known pregnancy
• Sickle cell hemaglobinopathy
• Concern for CNS infection
• Acute febrile illness
• non-frontal headaches
• Concern for increased intracranial pressure

Sponsors & Collaborators

• Newark Beth Israel Medical Center: lead

Study Sites (1)

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

RECRUITING

MeSH Terms

Conditions

Facial Neuralgia

Interventions

Lidocaine; Prochlorperazine

Condition Hierarchy (Ancestors)

Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenothiazines; Sulfur Compounds; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Adam Sivitz, MD

  Newark Beth Israel Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam Sivitz, MD

CONTACT

973 926 2484; adam.sivitz@rwjbh.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Pharmacy sends down drug and placebo in study preparations for administration.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director Pediatric Emergency Medicine

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 12, 2019
• Study Start: June 6, 2019
• Primary Completion: June 30, 2022
• Study Completion: December 30, 2022
• Last Updated: November 17, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)