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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPG block | Experimental | 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 |
|
| Control | Active Comparator | Delivered through IV access obtained in all patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine topical | Drug | Intranasal 2% lidocaine delivered directly to SPG |
| |
| 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 |
| 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 |
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Inclusion Criteria:
- Frontal migraine headache
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adam Sivitz, MD | Contact | 973 926 2484 | adam.sivitz@rwjbh.org |
| Name | Affiliation | Role |
|---|---|---|
| Adam Sivitz, MD | Newark Beth Israel Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newark Beth Israel Medical Center | Recruiting | Newark | New Jersey | 07112 | United States |
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| ID | Term |
|---|---|
| D005156 | Facial Neuralgia |
| ID | Term |
|---|---|
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D011346 | Prochlorperazine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Pharmacy sends down drug and placebo in study preparations for administration.
| Prochlorperazine Injection |
| Drug |
intravenous prochlorperazine at 0.15mg/kg max 10 mg |
|
| 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. |
| D009422 |
| Nervous System Diseases |
| Aniline Compounds |
| D000588 | Amines |
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |