Brief Summary
This is a randomized study of intravenous metoclopramide + intravenous dexamethasone versus intravenous metoclopramide for patients with acute post-traumatic headache.
Brief Title
Dexamethasone for Post Traumatic Headache
Categories
Completion Date
Completion Date Type
Actual
Conditions
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
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
Inclusion 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
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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
16 Years
NCT Id
NCT04799015
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2020-12625
Overall Status
Completed
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Randomized Study of Dexamethasone as Adjuvant Therapy for Acute Post-traumatic Headache
Primary Outcomes
Outcome Description
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.
Outcome Measure
Frequency of Moderate or Severe Headache After Emergency Department (ED) Discharge
Outcome Time Frame
From ED discharge to 48-hours following discharge from the ED, up to 2 days total
Secondary Ids
Secondary Id
UL1TR001073
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
48 hours after administration of study medication
Outcome Measure
Sustained Headache Relief
Outcome Description
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.
Outcome Time Frame
48 hours after ED discharge, up to 2 days total
Outcome Measure
Post Concussive Symptoms
Outcome Description
Post concussive symptoms at 7 days 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 greater severity of post-concussive symptoms. Results will be summarized by study arm using basic descriptive statistics.
Outcome Time Frame
7 days after ED discharge, up to 7 days total
Outcome Measure
Post Concussive Symptoms
Outcome Description
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.
Outcome Time Frame
Duration of ED admission, less than 1 day
Outcome Measure
Use of Rescue Medication in the ED
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
16
Investigators
Investigator Type
Principal Investigator
Investigator Name
Benjamin Friedman
Investigator Email
befriedm@montefiore.org
Investigator Phone
646-265-6415
Categories Mesh Debug
Headaches & Migraine --- HEADACHE DISORDERS, SECONDARY
Brain, Spinal Cord & Nervous System --- HEADACHE DISORDERS
Headaches & Migraine --- HEADACHE DISORDERS
Brain, Spinal Cord & Nervous System --- BRAIN DISEASES
Brain, Spinal Cord & Nervous System --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spinal Cord & Nervous System --- NERVOUS SYSTEM DISEASES
MeSH Terms
POST-TRAUMATIC HEADACHE
HEADACHE DISORDERS, SECONDARY
HEADACHE DISORDERS
BRAIN DISEASES
CENTRAL NERVOUS SYSTEM DISEASES
NERVOUS SYSTEM DISEASES
DEXAMETHASONE
METOCLOPRAMIDE
PREGNADIENETRIOLS
PREGNADIENES
PREGNANES
STEROIDS
FUSED-RING COMPOUNDS
POLYCYCLIC COMPOUNDS
STEROIDS, FLUORINATED
BENZAMIDES
AMIDES
ORGANIC CHEMICALS
PARA-AMINOBENZOATES
AMINOBENZOATES
BENZOATES
ACIDS, CARBOCYCLIC
CARBOXYLIC ACIDS
CHLOROBENZOATES
HYDROXYBENZOATE ETHERS
HYDROXYBENZOATES
HYDROXY ACIDS
BENZENE DERIVATIVES
HYDROCARBONS, AROMATIC
HYDROCARBONS, CYCLIC
HYDROCARBONS
PHENYL ETHERS
PHENOLS