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
National Center for Advancing Translational Sciences (NCATS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomization occurred in a 1:1 ratio in blocks of four.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Moderate or Severe Headache After Emergency Department (ED) Discharge | From ED discharge to 48-hours following discharge from the ED, up to 2 days total | 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 grouped and summarized by study arm. The number/percentage of patients reporting a headache intensity level of "Mild" or "None" will also be grouped and 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Headache Relief | 48 hours after administration of study medication | Sustained headache pain relief will be defined as the number of patients achieving a headache intensity of "mild" or "none" after administration of study medication and who maintain that level for 48 hours without the use of rescue medication. The percentage of patients reporting a headache intensity level of either "mild" or "none" will be considered to have achieved and maintained sustained headache relief and will be summarized by study arm. |
| Post Concussive Symptoms | 48 hours after ED discharge, up to 2 days total | 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 greater severity of post-concussive symptoms. Results will be summarized by study arm using basic descriptive statistics. |
| Use of Rescue Medication in the ED | Duration of ED admission, less than 1 day | 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 who used rescue medication while in the ED will be summarized by study arm. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBenjamin Friedman, MD
Montefiore Medical Center
Participant flow
Recruitment details
The study was conducted in two emergency departments in the Bronx, New York. Enrollment commenced in June 2021 and completed in November 2024.
Pre-assignment details
2,220 patients were screened for participation and 162 were enrolled as research participants. Despite repeated attempts, 8 study participants within each arm were unable to be contacted after discharge from the ED.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 44.4 years STANDARD_DEVIATION 15.9 |
| Baseline Headache Intensity Moderate | 35 Participants |
| Baseline Headache Intensity Severe | 55 Participants |
| Headache Duration | 21 hours |
| Loss of Consciousness No | 53 Participants |
| Loss of Consciousness Not sure | 20 Participants |
| Loss of Consciousness Yes | 9 Participants |
| Mechanism of Injury Assault | 25 Participants |
| Mechanism of Injury Bumped into object | 35 Participants |
| Mechanism of Injury Fall | 71 Participants |
| Mechanism of Injury Motor vehicle collision | 7 Participants |
| Mechanism of Injury Object fell onto patient | 14 Participants |
| Mechanism of Injury Other/Unknown | 2 Participants |
| Post Concussive Symptoms | 33 score on a scale |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment United States | 81 participants |
| Sex: Female, Male Female | 63 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 81 | 0 / 81 |
| other Total, other adverse events | 12 / 81 | 9 / 81 |
| serious Total, serious adverse events | 0 / 81 | 0 / 81 |
Outcome results
None listed