Phase 4
N=162
Dexamethasone for Post Traumatic Headache
Post-Traumatic Headache
Bottom Line
View on ClinicalTrials.gov: NCT04799015 ↗Enrolled (actual)
162
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Frequency of Moderate or Severe Headache After Emergency Department (ED) Discharge — 31; 29; 42; 44 Participants — p=0.751
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dexamethasone (Drug); Metoclopramide 10mg (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Moderate or Severe Headache After Emergency Department (ED) Discharge |
31; 29; 42; 44 | 0.751 |
| SECONDARY Sustained Headache Relief |
10; 12; 67; 67 | — |
| SECONDARY Post Concussive Symptoms |
8; 9 | 0.650 |
| SECONDARY Post Concussive Symptoms |
8; 9 | 0.650 |
| SECONDARY Use of Rescue Medication in the ED |
12; 15; 69; 66 | — |
Summary
This is a randomized study of intravenous metoclopramide + intravenous dexamethasone versus intravenous metoclopramide for patients with acute post-traumatic headache.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04799015). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.