Metoclopramide for Post-Traumatic Headache. A Pilot Study

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

  • Post-Traumatic Headache

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