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SPG Block for Acute Pediatric Migraine

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ClinicalTrials.gov Identifier: NCT03984045
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Adam B Sivitz, MD, 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.

Condition or disease Intervention/treatment Phase
Migraine in Children Sphenopalatine Neuralgia Migraine in Adolescence Drug: Lidocaine topical Drug: Prochlorperazine Injection Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Pharmacy sends down drug and placebo in study preparations for administration.
Primary Purpose: Treatment
Official Title: Sphenopalatine Ganglion Block for Treating Acute Frontal Migraine Headache in Pediatric Patients
Actual Study Start Date : June 6, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

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




Primary Outcome Measures :
  1. Time to headache resolution [ Time Frame: treatment start to patient reported resolution, up to 6 hours ]
    Time to headache resolution in emergency department

  2. ED Length of stay [ Time Frame: Registration to discharge up to 6 hours ]
    treatment to discharge


Secondary Outcome Measures :
  1. Patient satisfaction: Rated on a Likert 100 millimeter scale [ Time Frame: 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)

  2. 24 hr follow up [ Time Frame: 1 day ]
    Presence of headache at 24 hrs

  3. Number of participants with treatment induced side effects [ Time Frame: 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.

  4. Determine adequacy of blinding [ Time Frame: 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.



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Ages Eligible for Study:   10 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984045


Contacts
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Contact: Adam Sivitz, MD 973 926 2484 adam.sivitz@rwjbh.org

Locations
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United States, New Jersey
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
Contact: Adam Sivitz, MD    973-926-2484    adam.sivitz@rwjbh.org   
Sponsors and Collaborators
Newark Beth Israel Medical Center
Investigators
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Principal Investigator: Adam Sivitz, MD Newark Beth Israel Medical Center

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Responsible Party: Adam B Sivitz, MD, Medical Director Pediatric Emergency Medicine, Newark Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT03984045     History of Changes
Other Study ID Numbers: 2018.42
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Migraine Disorders
Neuralgia
Facial Neuralgia
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases
Lidocaine
Prochlorperazine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action