Migrainous Headache Clinical Trial
Official title:
Treatment of Acute Migraine Headache in Children
Migraine is common in children and is one of the most common etiologies of headache leading to emergency room presentation in children. Despite this, few studies have investigated the treatment of acute migraine headache in the emergency room. We will perform a prospective, double-blind, placebo-controlled study of metoclopramide versus placebo in the treatment of acute migraine headache. The primary outcome will be the number of subjects headache free at two hours.
Status | Completed |
Enrollment | 31 |
Est. completion date | March 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 8 Years to 18 Years |
Eligibility |
Inclusion Criteria: 1. Males or Females age 8-18 years 2. Girls 11 years or older must have a negative urine/serum pregnancy test. 3. Diagnosis of pediatric migrainous headache. The criteria for pediatric migraine headache based on the most recent ICHD criteria are listed below. The requirement of 5 attacks (A) will not be required for this study, this making the diagnosis migrainous headache. As described elsewhere in the protocol, this change is required to make the study applicable to ED patients who require treatment before five attacks have occurred. Exclusion Criteria: 1. Evidence that headache is due to a secondary underlying disorder based on history or physical examination. 2. Pregnant or lactating females. 3. Any investigational drug use within 30 days. 4. Known to have a contraindication to metoclopramide or valproic acid such as pregnancy, liver disease, hematologic disease, or metabolic disease. 5. Have used metoclopramide (or other antidopaminergic medications) or valproic acid within two days of presentation. 6. Severe developmental disorders or mental retardation if insufficient information can be obtained to make a clear diagnosis of migraine or judge headache severity. 7. If patients re-present to the ED, they can not be re-enrolled. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
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Children's Hospital of Philadelphia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Number of Subjects With a Numeric Rating Scale Score (NRS) of Zero at Two Hours. | The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache. | 2 hours | No |
Secondary | The Number of Subjects With a NRS Score of Zero at One Hour. | The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache. | 1 hour | No |
Secondary | The Number of Subjects With a NRS Score of Zero at 24 Hours. | The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache. | 24 hours | No |
Secondary | Change in Headache Intensity as Measured by the NRS Score From Baseline to the One Hour Assessment. | The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache. | 1 hours | No |
Secondary | Change in Headache Intensity as Measured by the NRS Score From Baseline to the Two Hour Assessment. | The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache. | 2 hours | No |
Secondary | Change in Headache Intensity as Measured by the NRS Score From Baseline to the 24 Hour Assessment. | The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache. | 24 hours | No |