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SPG Block for Acute Pediatric Migraine

NCT ID: NCT03984045

Last Updated: 2021-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-06

Study Completion Date

2022-12-30

Brief Summary

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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

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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

Conditions

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Migraine in Children Sphenopalatine Neuralgia Migraine in Adolescence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Pharmacy sends down drug and placebo in study preparations for administration.

Study Groups

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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

Group Type EXPERIMENTAL

Lidocaine topical

Intervention Type DRUG

Intranasal 2% lidocaine delivered directly to SPG

Control

Delivered through IV access obtained in all patients.

Group Type ACTIVE_COMPARATOR

Prochlorperazine Injection

Intervention Type DRUG

intravenous prochlorperazine at 0.15mg/kg max 10 mg

Interventions

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Lidocaine topical

Intranasal 2% lidocaine delivered directly to SPG

Intervention Type DRUG

Prochlorperazine Injection

intravenous prochlorperazine at 0.15mg/kg max 10 mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Newark Beth Israel Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Adam B Sivitz, MD

Medical Director Pediatric Emergency Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adam Sivitz, MD

Role: PRINCIPAL_INVESTIGATOR

Newark Beth Israel Medical Center

Locations

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Newark Beth Israel Medical Center

Newark, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Adam Sivitz, MD

Role: CONTACT

Phone: 973 926 2484

Email: [email protected]

Facility Contacts

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Adam Sivitz, MD

Role: primary

Other Identifiers

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2018.42

Identifier Type: -

Identifier Source: org_study_id