SPG Block for Acute Pediatric Migraine

Study Overview
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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

Official Title
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Sphenopalatine Ganglion Block for Treating Acute Frontal Migraine Headache in Pediatric Patients

Conditions
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Migraine in Children, Sphenopalatine Neuralgia, Migraine in Adolescence

Intervention / Treatment
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* Drug: Lidocaine topical
* Drug: Prochlorperazine Injection


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPG block<br>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<br>* Intranasal 2% lidocaine delivered directly to SPG<br>|
| Active Comparator: Control<br>Delivered through IV access obtained in all patients. | Drug: Prochlorperazine Injection<br>* intravenous prochlorperazine at 0.15mg/kg max 10 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to headache resolution | Time to headache resolution in emergency department | treatment start to patient reported resolution, up to 6 hours | 
| ED Length of stay | treatment to discharge | Registration to discharge up to 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Within 6 hours from ED registration | 
| 24 hr follow up | Presence of headache at 24 hrs | 1 day | 
| 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. | 1 day | 
| 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. | Asked at time of patient discharge from the emergency department or at 1 hr. |