Intravenous Ketorolac and Metoclopramide for Pediatric Migraine in the Emergency Department (EDMigraine-4)
Probable Migraine, Migraine With Aura, Migraine Without Aura
About this trial
This is an interventional treatment trial for Probable Migraine focused on measuring migraine, pediatric, childhood, emergency department, ketorolac, metoclopramide, intravenous
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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)
Sites / Locations
- Alberta Children's Hospital
- Stollery Children's Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Metoclopramide, Ketorolac
Metoclopramide, Placebo
10 mL/kg IV 0.9% sodium chloride Metoclopramide 0.2 mg/kg (max 10 mg) IV Ketorolac 0.5 mg/kg (max 30 mg) IV
10 mL/kg IV 0.9% sodium chloride Metoclopramide 0.2 mg/kg (max 10 mg) IV Placebo (normal saline)