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 @ 1:17 PM
Ignite Modification Date:
2025-12-24 @ 1:17 PM
NCT ID:
NCT02492295
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 65
* Chief complaint consistent with the diagnosis of headache that meets 2 of the 4 following criteria (check all that apply):
* Unilateral Headache
* Pulsatile Sensation
* Moderate to Severe pain intensity
* Aggravation by physical activity or causing avoidance of physical activity (i.e. climbing stairs, walking)
* Headache is associated with at least one of the following symptoms (check all that apply):
* Nausea and/or vomiting
* Photophobia and/or phonophobia
* History of at least 5 similar headaches
* Within 6 hours of screening has received BOTH (via IV or PO):
1. A Non-Steroidal Anti-Inflammatory Drug (NSAID):
Ibuprofen / "Motrin" Naproxen / "Aleve" Ketorolac / "Toradol"
2. A Dopamine-Antagonist:
Metoclopramide / "Reglan" Prochlorperazine / "Compazine"
* Persists with 6/10 or greater pain at one hour after above treatment
* Emergency Department attending feels patient appropriate for propofol treatment
Exclusion Criteria:
* Allergy to the study medication / eggs / soy (medication components)
* Inability to provide written, informed consent
* Employee or in police custody
* Pregnant or breast-feeding
* Medical concerns: Chronic obstructive pulmonary disease, active asthma exacerbation, obstructive sleep apnea, morbid obesity (Body Mass Index \> 40), American Society of Anaesthesiologists class 3 or greater, actively intoxicated, Blood Pressure \< 110/70
* Meal or heavy snack within 3 hours of sedation time
* Will be driving themselves home from Emergency Department
* Opioid use within the last 6 hours
* Previously enrolled in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02492295
Study Brief:
Protocol Section:
NCT02492295