Metoclopramide for Post-Traumatic Headache. A Pilot Study

Study Overview
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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.

Official Title
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Metoclopramide for Post-Traumatic Headache. A Pilot Study

Conditions
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Post-Traumatic Headache

Intervention / Treatment
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* Drug: Metoclopramide
* Drug: Diphenhydramine


Participation Criteria
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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.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metoclopramide<br>Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes | Drug: Metoclopramide<br>* Intravenous medication drip<br>* Other names: Reglan;Drug: Diphenhydramine<br>* Intravenous medication drip<br>* Other names: Benadryl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Sustained Headache Relief | Sustained headache relief is defined as achieving a headache level of mild or none within two hours and maintaining a level of mild or none for 48 hours. Patient self-evaluated pain level is solicited every half hour for two hours in the Emergency Department and then by telephone 48 hours after medication administration. | 2 hours thru 48 hours after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Concussion Symptoms Assessed by Post-concussive Symptom Scale | The post-concussive symptom scale is a questionnaire administered verbally. The post-concussive symptom ranges from 0 to 132. 0= no post-concussive symptoms. 132= severe post-concussive symptoms. | 7 days | 
| Number of Participants Satisfied With Medication; Assessed by Self-evaluation | Satisfaction is measured by a positive response to the question Would you want to receive the same medication during a subsequent visit for post-traumatic headache? | 48 hours after treatment |