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Intravenous Ketorolac and Metoclopramide for Pediatric Migraine in the Emergency Department

NCT01596166 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2015-01-26

No results posted yet for this study

Summary

Migraine headaches are a common problem for children. When treatment at home fails, children may benefit from intravenous treatment administered in a hospital setting like the Emergency Department. Most treatments used however have only been tested in adults and the best treatment strategy for children is not always clear. The combination of more than one medication is frequently prescribed in Canadian Emergency Departments. The purpose of this study is to investigate whether the combination of ketorolac (an anti-inflammatory pain medication) and metoclopramide (an anti-nauseant that may also relieve migraine headaches) is better than metoclopramide by itself.

Conditions

  • Probable Migraine
  • Migraine With Aura
  • Migraine Without Aura

Interventions

DRUG

Ketorolac Tromethamine

Ketorolac 0.5 mg/kg (max 30 mg) IV

DRUG

Metoclopramide

Metoclopramide 0.2 mg/kg (max 10 mg) IV

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • University of Alberta

    lead OTHER

Principal Investigators

  • Lawrence P. Richer, MD, MSc · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01596166 on ClinicalTrials.gov