Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2025-12-24 @ 4:30 PM
NCT ID:
NCT01596166
Eligibility 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT01596166
Study Brief:
Protocol Section:
NCT01596166