MigrainePhase 1/2EDMigraine3NCT01073787
Intravenous Fluid for Pediatric Migraine in the Emergency Department
A Phase 1/2 study testing Normal saline in people with Migraine and Headache, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- What is being tested?
- Normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2010to Nov 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Stollery Children's Hospital Emergency Department
Edmonton, Alberta, T6G 2J3
About this study
Official title: Single-blind, Placebo-challenge Study of Intravenous Fluid Hydration in the Management of 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.
Read the 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.
- Being tested
- Normal saline
- Keywords
- migraine, headache, pediatric, children, Emergency Department
- Medical subject headings
- Migraine Disorders, Headache, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineDrug
Also called 0.9% sodium chloride and water
10 ml/kg of normal saline will be administered over 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Normal saline | Active comparator | Not described Receives: Drug: Normal saline |
| Normal saline and possible medication | Experimental | Not described Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 minutes
Secondary outcomes (5)
Nausea
Severity will be assessed using: (1) Visual Analogue Scale; (2) Four categories (none, mild, moderate, severe)
Measured: 30 minutes
Vomiting
Measured: 30 minutes
Use of rescue medication
Use of any rescue medication after leaving the Emergency Department
Measured: 24 hours
Headache recurrence
Recurrence or worsening of headache after leaving the Emergency Department
Measured: 24 hours
Return to Emergency Department
Return to Emergency Department for treatment of migraine within 24 hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startJul 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lawrence P Richer, MD, MSc, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073787
- Sponsor's protocol ID
- Pro00008034
- Acronym
- EDMigraine3
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2010
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25168404
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-blind, Placebo-challenge Study of Intravenous Fluid Hydration in the Management of Pediatric Migraine in the Emergency Department
- ClinicalTrials.gov ID
- NCT01073787
- Acronym / sponsor ID
- EDMigraine3 / Pro00008034
- Keywords
- migraine, headache, pediatric, children, Emergency Department
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Jul 2010 (actual)
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 23 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal saline | Active comparator | Drug: Normal saline |
| Normal saline and possible medication | Experimental | Drug: Normal saline |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal salineAlso: 0.9% sodium chloride and water10 ml/kg of normal saline will be administered over 30 minutes | Drug | Normal saline, Normal saline and possible medication |
Primary outcome
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)
5 secondary outcomes
Nausea
Time frame: 30 minutes
Vomiting
Time frame: 30 minutes
Use of rescue medication
Time frame: 24 hours
Headache recurrence
Time frame: 24 hours
Return to Emergency Department
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Results publication: PubMed 25168404Richer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence P Richer, MD, MSc principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Normal saline in people with Migraine and Headache, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache pain (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01073787, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.