Brief Summary
Post-traumatic headache is common. We are determining short and longer-term outcomes among patients treated for post-traumatic headache with IV metoclopramide.
Brief Title
Metoclopramide for Post-Traumatic Headache. A Pilot Study
Categories
Completion Date
Completion Date Type
Actual
Conditions
Post-Traumatic Headache
Eligibility Criteria
Inclusion Criteria:
* 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.
* The plan of the attending emergency physician must include treatment with parenteral metoclopramide.
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 monoamine oxidase inhibitors, and use of anti-rejection transplant medications. Patients will not be excluded for pregnancy or breast-feeding.
* 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.
* The plan of the attending emergency physician must include treatment with parenteral metoclopramide.
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 monoamine oxidase inhibitors, and use of anti-rejection transplant medications. Patients will not be excluded for pregnancy or breast-feeding.
Inclusion Criteria
Inclusion Criteria:
* 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.
* The plan of the attending emergency physician must include treatment with parenteral metoclopramide.
* 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.
* The plan of the attending emergency physician must include treatment with parenteral metoclopramide.
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
NCT03056352
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2017-7511
Overall Status
Completed
Phases
Phase 1
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Metoclopramide for Post-Traumatic Headache. A Pilot Study
Primary Outcomes
Outcome Description
Sustained headache relief is defined as achieving a headache level of "mild" or "none" within two hours and maintaining a level of "mild" or "none" for 48 hours. Patient self-evaluated pain level is solicited every half hour for two hours in the Emergency Department and then by telephone 48 hours after medication administration.
Outcome Measure
Number of Participants With Sustained Headache Relief
Outcome Time Frame
2 hours thru 48 hours after treatment
Secondary Outcomes
Outcome Description
The post-concussive symptom scale is a questionnaire administered verbally. The post-concussive symptom ranges from 0 to 132. 0= no post-concussive symptoms. 132= severe post-concussive symptoms.
Outcome Time Frame
7 days
Outcome Measure
Post Concussion Symptoms Assessed by Post-concussive Symptom Scale
Outcome Description
Satisfaction is measured by a positive response to the question "Would you want to receive the same medication during a subsequent visit for post-traumatic headache?"
Outcome Time Frame
48 hours after treatment
Outcome Measure
Number of Participants Satisfied With Medication; Assessed by Self-evaluation
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