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Intravenous Fluid for Pediatric Migraine in the Emergency Department (EDMigraine3)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01073787
First Posted: February 23, 2010
Last Update Posted: November 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lawrence Richer, University of Alberta
  Purpose
The purpose of this study is to evaluate the effect of intravenous fluid (0.9% sodium chloride and water) alone on headache pain in children with migraine visiting the Emergency Department.

Condition Intervention Phase
Migraine Headache Drug: Normal saline Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Single-blind, Placebo-challenge Study of Intravenous Fluid Hydration in the Management of Pediatric Migraine in the Emergency Department

Resource links provided by NLM:


Further study details as provided by Lawrence Richer, University of Alberta:

Primary Outcome Measures:
  • Headache pain [ Time Frame: 30 minutes ]
    Pain will be assessed using three measures: (1) Nine Faces Pain scale; (2) Visual Analogue Scale; and (3) Four categories (none, mild, moderate, or severe)


Secondary Outcome Measures:
  • Nausea [ Time Frame: 30 minutes ]
    Severity will be assessed using: (1) Visual Analogue Scale; (2) Four categories (none, mild, moderate, severe)

  • Vomiting [ Time Frame: 30 minutes ]
  • Use of rescue medication [ Time Frame: 24 hours ]
    Use of any rescue medication after leaving the Emergency Department

  • Headache recurrence [ Time Frame: 24 hours ]
    Recurrence or worsening of headache after leaving the Emergency Department

  • Return to Emergency Department [ Time Frame: 24 hours ]
    Return to Emergency Department for treatment of migraine within 24 hours


Enrollment: 46
Study Start Date: July 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Normal saline Drug: Normal saline
10 ml/kg of normal saline will be administered over 30 minutes
Other Name: 0.9% sodium chloride and water
Experimental: Normal saline and possible medication Drug: Normal saline
10 ml/kg of normal saline will be administered over 30 minutes
Other Name: 0.9% sodium chloride and water

Detailed Description:
Migraine is a common and disabling disorder for children. The pain may be severe and relatively few effective medications are approved for use in children. The Emergency Department (ED) remains an important resource for children suffering from migraine whom have not responded to their usual therapy. While a number of effective intravenous therapies have been studied in adults, there has been only one such study in children. As such, emergency physicians have little or no information about the safety and efficacy of these medications in children. However, the conduct of clinical trials where pain is the outcome measure is often limited by a high placebo-response rate. The expectation of treatment can significantly alter the response to medications especially when pain severity is the outcome measure. Moreover, the investigators have found that intravenous fluid alone may help to treat migraine headache in children. The investigators propose a study to examine the response to intravenous fluid hydration as initial therapy comparing a group with expectation of medication and another group without the initial expectation of medication. The results of the study will help to estimate the rate of response to intravenous fluid and to evaluate the placebo-effect (i.e. expectation of treatment) in studies of migraine treatment in the ED. Exposure to additional and possibly unnecessary medications will thus be minimized and the results of future trials more definitive on the effect of the study medication.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of migraine or probable migraine (with or without aura) per the International Classification of Headache Disorders (2nd edition)
  • Visiting the Emergency Department for migraine treatment
  • Emergency Department physician has chosen to administer intravenous medication
  • Has taken usual therapy at home or at least one does of either ibuprofen or acetaminophen in the Emergency Department

Exclusion Criteria:

  • Other probable cause for headache (e.g. ventriculoperitoneal shunt, neoplasm, intracranial cyst)
  • Head trauma causing loss of consciousness within 1 week of presentation
  • Fever (temperature > 38.5 oC)
  • Signs or symptoms of meningitis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01073787


Locations
Canada, Alberta
Stollery Children's Hospital Emergency Department
Edmonton, Alberta, Canada, T6G 2J3
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Lawrence P Richer, MD, MSc University of Alberta
  More Information

Publications:
Responsible Party: Lawrence Richer, Principal Investigator, University of Alberta
ClinicalTrials.gov Identifier: NCT01073787     History of Changes
Other Study ID Numbers: Pro00008034
First Submitted: February 22, 2010
First Posted: February 23, 2010
Last Update Posted: November 7, 2016
Last Verified: November 2016

Keywords provided by Lawrence Richer, University of Alberta:
migraine
headache
pediatric
children
Emergency Department

Additional relevant MeSH terms:
Emergencies
Migraine Disorders
Headache
Disease Attributes
Pathologic Processes
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms


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