Intravenous Ketorolac and Metoclopramide for Pediatric Migraine in the Emergency Department

NCT01596166 | Completed Phase 4

• 1 other identifier: EDMIGR-004-01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

migraine; pediatric; childhood; emergency department; ketorolac; metoclopramide; intravenous

Outcome Measures

Primary Outcomes (1)

• Mean reduction in pain intensity

  Measured on Visual Analogue Scale (VAS).

  2 hours

Secondary Outcomes (10)

• Pain freedom

  2 hours

• Headache relief - 33

  2 hours

• Headache relief - 50

  2 hours

• Presence of nausea

  2 hours

• Presence of vomiting

  2 hours

Study Arms (2)

Metoclopramide, Ketorolac

EXPERIMENTAL

1. 10 mL/kg IV 0.9% sodium chloride 2. Metoclopramide 0.2 mg/kg (max 10 mg) IV 3. Ketorolac 0.5 mg/kg (max 30 mg) IV

Drug: Ketorolac Tromethamine; Drug: Metoclopramide

Metoclopramide, Placebo

PLACEBO COMPARATOR

1. 10 mL/kg IV 0.9% sodium chloride 2. Metoclopramide 0.2 mg/kg (max 10 mg) IV 3. Placebo (normal saline)

Drug: Metoclopramide

Interventions

Ketorolac Tromethamine DRUG

Ketorolac 0.5 mg/kg (max 30 mg) IV

Also known as: Toradol, 74103-07-4

Metoclopramide, Ketorolac

Metoclopramide DRUG

Metoclopramide 0.2 mg/kg (max 10 mg) IV

Also known as: Maxeran, Reglan, 364-62-5

Metoclopramide, Ketorolac; Metoclopramide, Placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• A patient is legible to participate in this study if they meet the following criteria:
• Patient is between 6 and 17 years of age inclusive
• Treatment with usual therapy at home or at least one dose of oral ibuprofen or acetaminophen has not provided satisfactory relief
• Intravenous therapy is indicated in the opinion of the treating ED physician
• Patient has a history of migraine as defined by the International Classification of Headache Disorders - 2nd edition (Appendix 1) and meets the following criteria:
• During headache, at least 1 of the following: nausea and/or vomiting; two of five symptoms (photophobia, phonophobia, difficulty thinking, lightheadedness, or fatigue). Symptoms may be inferred from patient's behavior.
• Headache has at least 2 of the following characteristics: bifrontal/bitemporal or unilateral location; pulsating/throbbing quality; moderate or severe pain intensity; aggravation by or causing avoidance of routine physical activity. Symptoms may be inferred from patient's behavior.

You may not qualify if:

• A patient is not eligible to participate in the study if any of the following criteria apply:
• Patient has a contraindication to the use of metoclopramide or ketorolac in the opinion of the ED physician
• Patient has a ventriculoperitoneal shunt
• Patient has a fever (temperature \> 38.5 oC)
• Patient has meningismus or clinical suspicion of meningitis in the opinion of the ED physician
• Patient has a history of head trauma causing headache in the last 1 week prior to presentation to the ED
• Patient is unable to complete the efficacy assessments (e.g. language barrier)

Sponsors & Collaborators

• University of Alberta: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Stollery Children's Hospital

Edmonton, Alberta, T6G 2C8, Canada

Location

MeSH Terms

Conditions

Migraine with Aura; Migraine without Aura; Migraine Disorders; Emergencies

Interventions

Ketorolac Tromethamine; Metoclopramide

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Study Officials

• Lawrence P. Richer, MD, MSc

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: May 10, 2012
• Study Start: February 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: January 26, 2015

Record last verified: 2015-01

Locations

CA (2)