Treatment of Acute Migraine Headache in Children - Full Text View

Purpose

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.

Condition	Intervention	Phase
Migrainous Headache	Drug: Metoclopramide Other: Placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Treatment of Acute Migraine Headache in Children

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine

Drug Information available for: Metoclopramide Metoclopramide hydrochloride

U.S. FDA Resources

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:

The Number of Subjects With a Numeric Rating Scale Score (NRS) of Zero at Two Hours. [ Time Frame: 2 hours ]
The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.

Secondary Outcome Measures:

The Number of Subjects With a NRS Score of Zero at One Hour. [ Time Frame: 1 hour ]
The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.
The Number of Subjects With a NRS Score of Zero at 24 Hours. [ Time Frame: 24 hours ]
The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.
Change in Headache Intensity as Measured by the NRS Score From Baseline to the One Hour Assessment. [ Time Frame: 1 hours ]
The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.
Change in Headache Intensity as Measured by the NRS Score From Baseline to the Two Hour Assessment. [ Time Frame: 2 hours ]
The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.
Change in Headache Intensity as Measured by the NRS Score From Baseline to the 24 Hour Assessment. [ Time Frame: 24 hours ]
The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.


Enrollment:	31
Study Start Date:	August 2006
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Standard care including intravenous fluid, but no metoclopramide.	Other: Placebo Standard care including intravenous fluid, but no metoclopramide.
Active Comparator: Metoclopramide Standard care including intravenous fluid PLUS metoclopramide.	Drug: Metoclopramide Intravenous bolus administration. Other Name: Reglan

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Eligibility


Ages Eligible for Study:	8 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or Females age 8-18 years
Girls 11 years or older must have a negative urine/serum pregnancy test.
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:

Evidence that headache is due to a secondary underlying disorder based on history or physical examination.
Pregnant or lactating females.
Any investigational drug use within 30 days.
Known to have a contraindication to metoclopramide or valproic acid such as pregnancy, liver disease, hematologic disease, or metabolic disease.
Have used metoclopramide (or other antidopaminergic medications) or valproic acid within two days of presentation.
Severe developmental disorders or mental retardation if insufficient information can be obtained to make a clear diagnosis of migraine or judge headache severity.
If patients re-present to the ED, they can not be re-enrolled.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355394

Locations


United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Children's Hospital of Philadelphia

Investigators


Principal Investigator:	Nicholas S Abend, MD	Children's Hospital of Philadelphia

More Information


Responsible Party:	Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:	NCT00355394 History of Changes
Other Study ID Numbers:	2006-4-4755
Study First Received:	July 19, 2006
Results First Received:	January 8, 2013
Last Updated:	October 30, 2015

Additional relevant MeSH terms:


Headache Migraine Disorders Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Metoclopramide	Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Dopamine D2 Receptor Antagonists Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 18, 2017