Migraine in Children, Sphenopalatine Neuralgia, Migraine in Adolescence
Conditions
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
Interventions
Intranasal 2% lidocaine delivered directly to SPG
DRUGProchlorperazine Injection
intravenous prochlorperazine at 0.15mg/kg max 10 mg
Sponsors
Newark Beth Israel Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Pharmacy sends down drug and placebo in study preparations for administration.
Eligibility
Sex/Gender
ALL
Age
10 Years to 20 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to headache resolution | treatment start to patient reported resolution, up to 6 hours | Time to headache resolution in emergency department |
| ED Length of stay | Registration to discharge up to 6 hours | treatment to discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction: Rated on a Likert 100 millimeter scale | 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 | 1 day | Presence of headache at 24 hrs |
| Number of participants with treatment induced side effects | 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 | 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. |
Countries
United States
Contacts
Primary ContactAdam Sivitz, MD
Outcome results
None listed