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Metoclopramide for Post Traumatic Headache

Montefiore Medicine Academic Health System logo

Montefiore Medicine Academic Health System

Status and phase

Completed
Phase 3

Conditions

Post-Traumatic Headache

Treatments

Drug: Normal saline
Drug: Metoclopramide
Drug: Diphenhydramine

Study type

Interventional

Funder types

Other

Identifiers

NCT03220958
2017-7898

Details and patient eligibility

About

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.

Enrollment

160 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

160 participants in 2 patient groups, including a placebo group

Metoclopramide
Experimental group
Description:
Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip
Treatment:
Drug: Normal saline
Drug: Metoclopramide
Drug: Diphenhydramine
Placebo
Placebo Comparator group
Description:
Normal saline, administered as an intravenous drip
Treatment:
Drug: Normal saline

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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