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

University of Alberta

Status and phase

Completed

Phase 2

Phase 1

Conditions

Migraine

Headache

Treatments

Drug: Normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT01073787

Pro00008034

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 patients

Sex

All

Ages

5 to 17 years old

Volunteers

No 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