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Completed

NCT Number: NCT01073787

Intravenous Fluid for Pediatric Migraine in the Emergency Department

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.

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Key information

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Stollery Children's Hospital Emergency Department

Edmonton, Alberta, T6G 2J3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

normal saline

Drug

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

Other names: 0.9% sodium chloride and water

Primary outcomes

  1. 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 outcomes

  1. Nausea

    Time frame: 30 minutes

    Severity will be assessed using: (1) Visual Analogue Scale; (2) Four categories (none, mild, moderate, severe)

  2. Vomiting

    Time frame: 30 minutes

  3. Use of rescue medication

    Time frame: 24 hours

    Use of any rescue medication after leaving the Emergency Department

  4. Headache recurrence

    Time frame: 24 hours

    Recurrence or worsening of headache after leaving the Emergency Department

  5. Return to Emergency Department

    Time frame: 24 hours

    Return to Emergency Department for treatment of migraine within 24 hours

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

Single-blind, Placebo-challenge Study of Intravenous Fluid Hydration in the Management of Pediatric Migraine in the Emergency Department

Acronym: EDMigraine3

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 23, 2010
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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