Metoclopramide for Post Traumatic Headache

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Placebo Controlled Trial of IV Metoclopramide for Acute Post-traumatic Headache

Conditions
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Post-Traumatic Headache

Intervention / Treatment
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* Drug: Metoclopramide
* Drug: Diphenhydramine
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metoclopramide<br>Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip | Drug: Metoclopramide<br>* Metoclopramide 20mg<br>Drug: Diphenhydramine<br>* Diphenhydramine 25mg<br>Drug: Normal saline<br>* 100ml normal saline<br>|
| Placebo Comparator: Placebo<br>Normal saline, administered as an intravenous drip | Drug: Normal saline<br>* 100ml normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable | Improvement in this 0 to 10 verbal rating scale | 1 hour after medication administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Headache Relief | Achieving a headache intensity of mild or none in the ED without use of rescue medication and maintaining a level of mild or none. Participants rate their headache as none, mild, moderate, or severe | 48 hours after medication administration | 
| Headache Days | Number of days with any headache. Participants report the actual number of days they experienced headache. A day begins when they awake for the beginning of daily activities and ends when they go to sleep after completion of daily activities | 7 days after ED visit |