Intravenous Fluid for Pediatric Migraine in the Emergency Department

NCT ID: NCT01073787

Last Updated: 2016-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-11-30

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.

Conditions

Migraine; Headache

Keywords

migraine; headache; pediatric; children; Emergency Department

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Normal saline

Group Type: ACTIVE_COMPARATOR

Normal saline

Intervention Type: DRUG

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

Normal saline and possible medication

Group Type: EXPERIMENTAL

Normal saline

Intervention Type: DRUG

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

Interventions

Normal saline

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

Intervention Type: DRUG

Other Intervention Names

0.9% sodium chloride and water

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Lawrence Richer

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lawrence P Richer, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

Stollery Children's Hospital Emergency Department

Edmonton, Alberta, Canada

Countries

Canada

References

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.

Reference Type: RESULT

PMID: 25168404 (View on PubMed)

Other Identifiers

Pro00008034

Identifier Type: -

Identifier Source: org_study_id