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

Primary Purpose

Migraine, Headache

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Normal saline
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring migraine, headache, pediatric, children, Emergency Department

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stollery Children's Hospital Emergency Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Normal saline

Normal saline and possible medication

Arm Description

Outcomes

Primary Outcome Measures

Headache pain
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
Severity will be assessed using: (1) Visual Analogue Scale; (2) Four categories (none, mild, moderate, severe)
Vomiting
Use of rescue medication
Use of any rescue medication after leaving the Emergency Department
Headache recurrence
Recurrence or worsening of headache after leaving the Emergency Department
Return to Emergency Department
Return to Emergency Department for treatment of migraine within 24 hours

Full Information

First Posted
February 22, 2010
Last Updated
November 3, 2016
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT01073787
Brief Title
Intravenous Fluid for Pediatric Migraine in the Emergency Department
Acronym
EDMigraine3
Official Title
Single-blind, Placebo-challenge Study of Intravenous Fluid Hydration in the Management of Pediatric Migraine in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Headache
Keywords
migraine, headache, pediatric, children, Emergency Department

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal saline
Arm Type
Active Comparator
Arm Title
Normal saline and possible medication
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
0.9% sodium chloride and water
Intervention Description
10 ml/kg of normal saline will be administered over 30 minutes
Primary Outcome Measure Information:
Title
Headache pain
Description
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)
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Nausea
Description
Severity will be assessed using: (1) Visual Analogue Scale; (2) Four categories (none, mild, moderate, severe)
Time Frame
30 minutes
Title
Vomiting
Time Frame
30 minutes
Title
Use of rescue medication
Description
Use of any rescue medication after leaving the Emergency Department
Time Frame
24 hours
Title
Headache recurrence
Description
Recurrence or worsening of headache after leaving the Emergency Department
Time Frame
24 hours
Title
Return to Emergency Department
Description
Return to Emergency Department for treatment of migraine within 24 hours
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence P Richer, MD, MSc
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stollery Children's Hospital Emergency Department
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2J3
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25168404
Citation
Richer L, Craig W, Rowe B. Randomized controlled trial of treatment expectation and intravenous fluid in pediatric migraine. Headache. 2014 Oct;54(9):1496-505. doi: 10.1111/head.12443. Epub 2014 Aug 28.
Results Reference
result

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Intravenous Fluid for Pediatric Migraine in the Emergency Department

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