Brief Summary
Nearly 1.5 million patients present to US emergency departments annually following head trauma. Headache is a frequent symptom of victims of head trauma. The purpose of this study is to see if an intravenous medication called metoclopramide can improve the symptoms of patients with acute post-traumatic headache.
Brief Title
Metoclopramide for Post Traumatic Headache
Categories
Completion Date
Completion Date Type
Actual
Conditions
Post-Traumatic Headache
Eligibility Criteria
Inclusion Criteria:
Included patients will be adults who meet International Classification of Headache Disorders criteria for acute post-traumatic headache. These are 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 (eg, previous history of migraine or tension-type headache)
The headache must be rated as moderate or severe in intensity at the time of initial evaluation.
Exclusion Criteria:
Patients will be excluded if more than ten days have elapsed since the head trauma, if the headache has already been treated with an anti-dopaminergic medication, or for medication contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of anti-rejection transplant medications.
Included patients will be adults who meet International Classification of Headache Disorders criteria for acute post-traumatic headache. These are 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 (eg, previous history of migraine or tension-type headache)
The headache must be rated as moderate or severe in intensity at the time of initial evaluation.
Exclusion Criteria:
Patients will be excluded if more than ten days have elapsed since the head trauma, if the headache has already been treated with an anti-dopaminergic medication, or for medication contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of anti-rejection transplant medications.
Inclusion Criteria
Inclusion Criteria:
Included patients will be adults who meet International Classification of Headache Disorders criteria for acute post-traumatic headache. These are 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 (eg, previous history of migraine or tension-type headache)
The headache must be rated as moderate or severe in intensity at the time of initial evaluation.
Included patients will be adults who meet International Classification of Headache Disorders criteria for acute post-traumatic headache. These are 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 (eg, previous history of 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
18 Years
NCT Id
NCT03220958
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2017-7898
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Randomized Placebo Controlled Trial of IV Metoclopramide for Acute Post-traumatic Headache
Primary Outcomes
Outcome Description
Improvement in this 0 to 10 verbal rating scale
Outcome Measure
0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable
Outcome Time Frame
1 hour after medication administration
Secondary Outcomes
Outcome Description
Achieving a headache intensity of mild or none in the ED without use of rescue medication and maintaining a level of mild or none. Participants rate their headache as none, mild, moderate, or severe
Outcome Time Frame
48 hours after medication administration
Outcome Measure
Sustained Headache Relief
Outcome Description
Number of days with any headache. Participants report the actual number of days they experienced headache. A "day" begins when they awake for the beginning of daily activities and ends when they go to sleep after completion of daily activities
Outcome Time Frame
7 days after ED visit
Outcome Measure
Headache Days
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
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Benjamin Friedman
Investigator Email
befriedm@montefiore.org
Investigator Phone
646-265-6415