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 @ 11:05 PM
Ignite Modification Date:
2025-12-24 @ 11:05 PM
NCT ID:
NCT03221569
Eligibility Criteria:
Inclusion Criteria:
* The inclusion criteria are: Patients 18-65 years old who provides informed consent and presents to the ED with an acute tension type headache (TTH), as classified by meeting the following:
1. Have at least 10 episodes of headache occurring on average less than 12 days per year AND Fullfuling B-D B. Lasting 30mins to 7 days C. At least 2 of the following 4 criteria
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1. bilateral location
2. pressing/tightening (non-pulsating)
3. mild or moderate
4. not aggravated by routine physical activity such as walking or climbing stairs D. Both of the following
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1. no nausea/vomiting
2. No more than one of photophobia or phonophobia
Exclusion Criteria: Non migraine primary headache disorder or unclassifiable, previous enrollment in study, fever \>100.3, Patients with suspected secondary headache disorder such as SAH or sinusitis, performance of lumbar puncture or potential need for LP, Severe hypertension (≥180/100), History of CAD or hypertension, presence of/suspected for traumatic head injury in the past 30 days with or without loss of consciousness, Presence of/suspected for myocardial ischemia, presence of/suspected for alcohol intoxication, Hemodynamic instability, history of psychiatric disorders, known or suspected pregnancy or breast feeding, allergy to ketamine, ketorolac, previous enrollment in the study, patients with language barriers, refusal to provide consent to receive intravenous therapy, reported illicit drug use within the past 5 days, patients weighing over 100kg
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03221569
Study Brief:
Protocol Section:
NCT03221569