Dexamethasone for Post Traumatic Headache (NCT04799015) | Clinical Trial Compass
CompletedPhase 4
Dexamethasone for Post Traumatic Headache
United States162 participantsStarted 2021-06-25
Plain-language summary
This is a randomized study of intravenous metoclopramide + intravenous dexamethasone versus intravenous metoclopramide for patients with acute post-traumatic headache.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Meet International Classification of Headache Disorders (3rd edition) criteria for acute post-traumatic headache as follows:
* Traumatic injury to the head has occurred
* Headache has developed within 7 days of injury to the head
* Headache is not better accounted for by another diagnosis (e.g., migraine or tension-type headache)
* The headache must be rated as moderate or severe in intensity at the time of initial evaluation
Exclusion Criteria:
* More than ten days have elapsed since the head trauma
* Headache has already been treated with an anti-dopaminergic medication
* Medication allergies
* Contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of Monoamine oxidase (MAO) inhibitors, and use of anti-rejection transplant medications
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested dexamethasone — a steroid — to reduce moderate or severe headaches after an ER visit for a head injury; given that this trial is now completed, has the data been published, and what did it show about whether the steroid actually helped?
2Since dexamethasone is already an approved medication being studied here in a Phase 4 trial, does that mean its general safety profile is already well understood, and are there specific short-term side effects — like sleep disruption, blood sugar changes, or stomach irritation — that I should watch out for if this approach is considered for me?
3The trial focused on headache frequency after leaving the emergency department — so is this treatment meant as a short-term rescue option right after a head injury, or could it play a role in my longer-term post-traumatic headache management?
4Are there certain types of patients — based on severity of head injury, age, or other medications — for whom dexamethasone worked better or worse in this kind of study, and how does my situation compare?
5Since this trial is completed, would my doctor consider the findings relevant to my care right now, or are there other current treatments or trials for post-traumatic headache that might be a better fit for me to explore?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of Moderate or Severe Headache After Emergency Department (ED) Discharge
Timeframe: From ED discharge to 48-hours following discharge from the ED, up to 2 days total