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出境医 / 临床实验 / SPG Block for Acute Pediatric Migraine

SPG Block for Acute Pediatric Migraine

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.

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
Study Design
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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
Arms and Interventions
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
Outcome Measures
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.


Eligibility Criteria
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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
Contacts and Locations

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
Tracking Information
First Submitted Date  ICMJE June 6, 2019
First Posted Date  ICMJE June 12, 2019
Last Update Posted Date June 12, 2019
Actual Study Start Date  ICMJE June 6, 2019
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • Time to headache resolution [ Time Frame: treatment start to patient reported resolution, up to 6 hours ]
    Time to headache resolution in emergency department
  • ED Length of stay [ Time Frame: Registration to discharge up to 6 hours ]
    treatment to discharge
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • 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)
  • 24 hr follow up [ Time Frame: 1 day ]
    Presence of headache at 24 hrs
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SPG Block for Acute Pediatric Migraine
Official Title  ICMJE Sphenopalatine Ganglion Block for Treating Acute Frontal Migraine Headache in Pediatric Patients
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • Migraine in Children
  • Sphenopalatine Neuralgia
  • Migraine in Adolescence
Intervention  ICMJE
  • Drug: Lidocaine topical
    Intranasal 2% lidocaine delivered directly to SPG
  • Drug: Prochlorperazine Injection
    intravenous prochlorperazine at 0.15mg/kg max 10 mg
Study Arms  ICMJE
  • 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
    Intervention: Drug: Lidocaine topical
  • Active Comparator: Control
    Delivered through IV access obtained in all patients.
    Intervention: Drug: Prochlorperazine Injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2019) 		72
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Adam Sivitz, MD 973 926 2484 adam.sivitz@rwjbh.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03984045
Other Study ID Numbers  ICMJE 2018.42
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Adam B Sivitz, MD, Newark Beth Israel Medical Center
Study Sponsor  ICMJE Newark Beth Israel Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Adam Sivitz, MD Newark Beth Israel Medical Center
PRS Account Newark Beth Israel Medical Center
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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