Print

Purpose

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.

Condition

Eligibility

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

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Metoclopramide 		Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip
  • Drug: Metoclopramide
    Metoclopramide 20mg
  • Drug: Diphenhydramine
    Diphenhydramine 25mg
  • Drug: Normal saline
    100ml normal saline
Placebo Comparator
Placebo 		Normal saline, administered as an intravenous drip
  • Drug: Normal saline
    100ml normal saline

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.