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Purpose

Post-traumatic headache is common. We are determining short and longer-term outcomes among patients treated for post-traumatic headache with IV metoclopramide.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Metoclopramide 		Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes
  • Drug: Metoclopramide
    Intravenous medication drip
    Other names:
    • Reglan
  • Drug: Diphenhydramine
    Intravenous medication drip
    Other names:
    • Benadryl

More Details

Status
Completed
Sponsor
Montefiore Medical Center

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.