Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
162 participants
INTERVENTIONAL
2021-02-24
2024-12-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dexamethasone
Dexamethasone 10mg IV + metoclopramide 10mg IV
Dexamethasone
Dexamethasone 10mg IV
Metoclopramide 10mg
Metoclopramide 10mg IV
Placebo
Placebo IV + metoclopramide 10mg IV
Metoclopramide 10mg
Metoclopramide 10mg IV
Interventions
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Dexamethasone
Dexamethasone 10mg IV
Metoclopramide 10mg
Metoclopramide 10mg IV
Eligibility Criteria
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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 (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
* 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
16 Years
ALL
No
Sponsors
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Montefiore Medical Center
OTHER
Responsible Party
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Principal Investigators
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Benjamin Friedman, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
Locations
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Montefiore
The Bronx, New York, United States
Countries
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Other Identifiers
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2020-12625
Identifier Type: -
Identifier Source: org_study_id
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