Recruiting
Phase 3

SPG Block

Sponsor:

Newark Beth Israel Medical Center

Code:

NCT03984045

Conditions

Migraine in Children

Sphenopalatine Neuralgia

Migraine in Adolescence

Eligibility Criteria

Sex: All

Age: 10 - 20

Healthy Volunteers: Not accepted

Interventions

Lidocaine topical

Prochlorperazine Injection

Study Details

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

Study ID

NCT03984045

Start date

Jun 6, 2019

Status verified date

Nov, 2021

Completion date

Dec 30, 2022

Anticipated

Primary completion date

Jun 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 20

Healthy Volunteers: Not accepted

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

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

active comparator: Control

Delivered through IV access obtained in all patients.

Interventions

Lidocaine topical

Intranasal 2% lidocaine delivered directly to SPG

Prochlorperazine Injection

intravenous prochlorperazine at 0.15mg/kg max 10 mg

Primary outcome measure

  • Time to headache resolution [ Time Frame: treatment start to patient reported resolution, up to 6 hours ]
  • ED Length of stay [ Time Frame: Registration to discharge up to 6 hours ]

Central Contacts and Locations

Central contacts

Adam Sivitz, MD

973 926 2484adam.sivitz@rwjbh.org

Locations

Newark Beth Israel Medical Center

Recruiting

Newark, New Jersey, United States, 07112

Contacts

Adam Sivitz, MD

973-926-2484adam.sivitz@rwjbh.org

More Information

Sponsor

Newark Beth Israel Medical Center

Last update posted

Nov 17, 2021

Last verified

Nov, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Newark Beth Israel Medical Center on 2021-11-17.