NCT01073787

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2010

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

2.3 years

First QC Date

February 22, 2010

Last Update Submit

February 3, 2026

Conditions

MigraineHeadache

Keywords

migraineheadachepediatricchildrenEmergency Department

Outcome Measures

Primary Outcomes (1)

  • 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)

    30 minutes

Secondary Outcomes (5)

  • Nausea

    30 minutes

  • Vomiting

    30 minutes

  • Use of rescue medication

    24 hours

  • Headache recurrence

    24 hours

  • Return to Emergency Department

    24 hours

Study Arms (2)

Normal saline

ACTIVE COMPARATOR
Drug: Normal saline

Normal saline and possible medication

EXPERIMENTAL
Drug: Normal saline

Interventions

Normal salineDRUG

10 ml/kg of normal saline will be administered over 30 minutes

Also known as: 0.9% sodium chloride and water
Normal salineNormal saline and possible medication

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stollery Children's Hospital Emergency Department

Edmonton, Alberta, T6G 2J3, Canada

Location

Related Publications (1)

  • 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.

    PMID: 25168404RESULT

MeSH Terms

Conditions

Migraine DisordersHeadacheEmergencies

Interventions

Saline SolutionSodium ChlorideWater

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsHydroxidesAlkaliesAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Lawrence P Richer, MD, MSc

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2010

First Posted

February 23, 2010

Study Start

July 1, 2010

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations

CA(1)