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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
Intranasal 2% lidocaine delivered directly to SPG
intravenous prochlorperazine at 0.15mg/kg max 10 mg
Newark Beth Israel Medical Center
Newark, New Jersey, United States
RECRUITINGTime to headache resolution
Time to headache resolution in emergency department
Time frame: treatment start to patient reported resolution, up to 6 hours
ED Length of stay
treatment to discharge
Time frame: Registration to discharge up to 6 hours
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)
Time frame: Within 6 hours from ED registration
24 hr follow up
Presence of headache at 24 hrs
Time frame: 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.
Time frame: 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.
Time frame: Asked at time of patient discharge from the emergency department or at 1 hr.
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