Post-Traumatic Headache
Conditions
Brief summary
This is a randomized study of intravenous metoclopramide + intravenous dexamethasone versus intravenous metoclopramide for patients with acute post-traumatic headache.
Interventions
DRUGDexamethasone
Dexamethasone 10mg IV
Metoclopramide 10mg IV
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Meet International Classification of Headache Disorders 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 MAO inhibitors, and use of anti-rejection transplant medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency Moderate or Severe headache after Emergency Department (ED) discharge | Up to 48 hours after ED discharge | Headache intensity will be rated based on the International Headache Society (IHS) 4-point scale. Using this scale participants will verbalize whether their headache intensity is severe, moderate, mild, or none. The percentage of patients reporting a headache intensity level of either moderate or 'severe will be summarized by study arm. Between-group difference along with 95% confidence intervals will be reported. Patients who use an analgesic or abortive headache medication during the 48 hour period will be considered an outcome failure and their results will not be included in the analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sustained headache relief | 48 hours after ED discharge | Sustained headache relief will be defined as the number of patients achieving a headache intensity of mild or none and who maintain that level for 48 hours after ED discharge without the use of rescue medication. The percentage of patients reporting both headache intensity level of either moderate or 'severe will be summarized by study arm. |
| Post concussive symptoms | 48 hours after ED discharge | Post concussive symptoms at 48 hours will be assessed using the Sport Concussion Assessment Tool (SCAT) Post Concussion Symptom Scale (PCSS). Using the validated SCAT PCSS patients rate the severity of 22 concussive symptoms on a 7-point Likert scale ranging from 0 (none) to 6 (severe) yielding an overall possible scoring range of 0-132. Higher SCAT PCSS scores are indicative of more severe level of post-concussive symptoms. Results will be summarized by study arm using basic descriptive statistics. |
| Use of Rescue medication | Duration of ED admission, up to 3-4 days | Use of rescue medication will be defined as the number of patients administered any analgesic medication or headache abortive medication while in the ED. The number of patients using rescue medication will be summarized by study arm. |
Countries
United States
Outcome results
None listed