Clinical trial NCT01073787: Intravenous Fluid for Pediatric Migraine in the Emergency Department
Official title: Single-blind, Placebo-challenge Study of Intravenous Fluid Hydration in the Management of Pediatric Migraine in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Migraine
Headache
Keywords: migraine
headache
pediatric
children
Emergency Department
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2010-02-23
Enrollment: 46
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Headache pain
timeFrame: 30 minutes
Secondary outcomes:
measure: Nausea
timeFrame: 30 minutes
measure: Vomiting
timeFrame: 30 minutes
measure: Use of rescue medication
timeFrame: 24 hours
measure: Headache recurrence
timeFrame: 24 hours
measure: Return to Emergency Department
timeFrame: 24 hours
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Stollery Children's Hospital Emergency Department
state: Alberta
Study officials:
affiliation: University of Alberta
name: Lawrence P Richer, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.