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:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
NCT ID:
NCT01534806
Eligibility Criteria:
Inclusion Criteria:
1. patient aged 8-18 years presenting to Akron Children's Hospital (ACH) ED with complaint of headache
2. patient has an established diagnosis of migraine without aura or as established by history meets the criteria for migraine headache as defined by the International Criteria for Headache Disorder -II in 2004 a. At least 5 episodes of headache b. The headache should last between 1-72 hours c. The headache should include two of the following: i. Unilateral location, though may be bifrontal or frontotemporal in location but should not be occipital ii. Pulsing quality iii. Moderate to severe pain iv. Aggravation by or causing avoidance of routine physical activity d. One of the following symptoms should accompany the headache i. Nausea or vomiting ii. Photophobia or phonophobia e. The headache should not be attributed to another disorder based on history, physical and/or laboratory information.
Exclusion Criteria:
1. Patients with a contraindication to receiving prochlorperazine, ketorolac, diphenhydramine, or naproxen
2. Patients unable to complete the pain scale.
3. Patients on medications that will have a drug-drug interaction with the study medication including prochlorperazine, ketorolac, diphenhydramine or naproxen.
4. Patients with any medical condition that may be contributing or associated with the current headache such as concussion or trauma
5. Female patients with a positive urine HCG point of care test
6. Patients with diagnosis of or suspected to have chronic daily headaches defined as a headache lasting at least 4 hours for more than 15 days a month for the past 3 months.
7. Patients who received prochlorperazine or ketorolac in the past 48 hours.
8. Patients who had previously been randomized in this study in the past 3 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
18 Years
Study:
NCT01534806
Study Brief:
Protocol Section:
NCT01534806