Metoclopramide for Post-Traumatic Headache. A Pilot Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2017-08-15

Brief Summary

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

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Detailed Description

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Conditions

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Post-Traumatic Headache

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metoclopramide

Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes

Group Type EXPERIMENTAL

Metoclopramide

Intervention Type DRUG

Intravenous medication drip

Diphenhydramine

Intervention Type DRUG

Intravenous medication drip

Interventions

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Metoclopramide

Intravenous medication drip

Intervention Type DRUG

Diphenhydramine

Intravenous medication drip

Intervention Type DRUG

Other Intervention Names

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Reglan Benadryl

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 (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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No