Intravenous Ketorolac and Metoclopramide for Pediatric Migraine in the Emergency Department

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alberta
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Treatments: Ketorolac; Ketorolac Tromethamine; Metoclopramide

Criteria

Inclusion Criteria:

A patient is legible to participate in this study if they meet the following criteria:

1. Patient is between 6 and 17 years of age inclusive

2. Treatment with usual therapy at home or at least one dose of oral ibuprofen or acetaminophen has not provided satisfactory relief

3. Intravenous therapy is indicated in the opinion of the treating ED physician

4. Patient has a history of migraine as defined by the International Classification of Headache Disorders - 2nd edition (Appendix 1) and meets the following criteria:

1. 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.

2. 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.

Exclusion Criteria:

A patient is not eligible to participate in the study if any of the following criteria apply:

1. Patient has a contraindication to the use of metoclopramide or ketorolac in the opinion of the ED physician

2. Patient has a ventriculoperitoneal shunt

3. Patient has a fever (temperature > 38.5 oC)

4. Patient has meningismus or clinical suspicion of meningitis in the opinion of the ED physician

5. Patient has a history of head trauma causing headache in the last 1 week prior to presentation to the ED

6. Patient is unable to complete the efficacy assessments (e.g. language barrier)