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

This study is currently recruiting participants.
Verified May 2012 by University of Alberta
Sponsor:
Information provided by (Responsible Party):
Lawrence Richer, University of Alberta
ClinicalTrials.gov Identifier:
NCT01073787
First received: February 22, 2010
Last updated: May 2, 2012
Last verified: May 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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:

U.S. FDA Resources

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Headache pain [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Severity will be assessed using: (1) Visual Analogue Scale; (2) Four categories (none, mild, moderate, severe)

  • Vomiting [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Use of rescue medication [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Use of any rescue medication after leaving the Emergency Department

  • Headache recurrence [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Recurrence or worsening of headache after leaving the Emergency Department

  • Return to Emergency Department [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Return to Emergency Department for treatment of migraine within 24 hours


Estimated Enrollment: 60
Study Start Date: March 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 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

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01073787

Contacts
Contact: Lawrence P Richer, MD, MSc 780-407-7329 lricher@ualberta.ca
Contact: William Craig, MD, MSc 780-407-3555 William.Craig@albertahealthservices.ca

Locations
Canada, Alberta
Stollery Children's Hospital Emergency Department Recruiting
Edmonton, Alberta, Canada, T6G 2J3
Contact: Lawrence P Richer, MD, MSc     780-407-7329     lricher@ualberta.ca    
Contact: William Craig, MD, MSc     780-407-3555     william.craig@albertahealthservices.ca    
Principal Investigator: Lawrence P Richer, MD, MSc            
Sub-Investigator: William Craig, MD, MSc            
Sub-Investigator: Brian Rowe, MD, MSc            
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Lawrence P Richer, MD, MSc University of Alberta
  More Information

No publications provided

Responsible Party: Lawrence Richer, Principal Investigator, University of Alberta
ClinicalTrials.gov Identifier: NCT01073787     History of Changes
Other Study ID Numbers: Pro00008034
Study First Received: February 22, 2010
Last Updated: May 2, 2012
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on May 22, 2013