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SPG Block for Acute Pediatric Migraine

Primary Purpose

Migraine in Children, Sphenopalatine Neuralgia, Migraine in Adolescence

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lidocaine topical
Prochlorperazine Injection
Sponsored by
Newark Beth Israel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine in Children

Eligibility Criteria

10 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Newark Beth Israel Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SPG block

Control

Arm Description

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

Delivered through IV access obtained in all patients.

Outcomes

Primary Outcome Measures

Time to headache resolution
Time to headache resolution in emergency department
ED Length of stay
treatment to discharge

Secondary Outcome Measures

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)
24 hr follow up
Presence of headache at 24 hrs
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.
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.

Full Information

First Posted
June 6, 2019
Last Updated
November 16, 2021
Sponsor
Newark Beth Israel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03984045
Brief Title
SPG Block for Acute Pediatric Migraine
Official Title
Sphenopalatine Ganglion Block for Treating Acute Frontal Migraine Headache in Pediatric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2019 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Newark Beth Israel Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine in Children, Sphenopalatine Neuralgia, Migraine in Adolescence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Pharmacy sends down drug and placebo in study preparations for administration.
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SPG block
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Delivered through IV access obtained in all patients.
Intervention Type
Drug
Intervention Name(s)
Lidocaine topical
Intervention Description
Intranasal 2% lidocaine delivered directly to SPG
Intervention Type
Drug
Intervention Name(s)
Prochlorperazine Injection
Intervention Description
intravenous prochlorperazine at 0.15mg/kg max 10 mg
Primary Outcome Measure Information:
Title
Time to headache resolution
Description
Time to headache resolution in emergency department
Time Frame
treatment start to patient reported resolution, up to 6 hours
Title
ED Length of stay
Description
treatment to discharge
Time Frame
Registration to discharge up to 6 hours
Secondary Outcome Measure Information:
Title
Patient satisfaction: Rated on a Likert 100 millimeter scale
Description
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)
Time Frame
Within 6 hours from ED registration
Title
24 hr follow up
Description
Presence of headache at 24 hrs
Time Frame
1 day
Title
Number of participants with treatment induced side effects
Description
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.
Time Frame
1 day
Title
Determine adequacy of blinding
Description
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.
Time Frame
Asked at time of patient discharge from the emergency department or at 1 hr.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam Sivitz, MD
Phone
973 926 2484
Email
adam.sivitz@rwjbh.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Sivitz, MD
Organizational Affiliation
Newark Beth Israel Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Sivitz, MD
Phone
973-926-2484
Email
adam.sivitz@rwjbh.org

12. IPD Sharing Statement

Plan to Share IPD
No

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SPG Block for Acute Pediatric Migraine

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