Metoclopramide for Post Traumatic Headache

Phase 3

Completed

Conditions: Post-Traumatic Headache

Interventions: Drug: Metoclopramide
Drug: Diphenhydramine
Drug: Normal saline

Registration Number: NCT03220958

Lead Sponsor: Montefiore Medical Center

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 160

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metoclopramide	Normal saline	Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip
Placebo	Normal saline	Normal saline, administered as an intravenous drip
Metoclopramide	Metoclopramide	Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip
Metoclopramide	Diphenhydramine	Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip

Primary Outcome Measures

Name	Time	Method
0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable	1 hour after medication administration	Improvement in this 0 to 10 verbal rating scale

Secondary Outcome Measures

Name	Time	Method
Sustained Headache Relief	48 hours after medication administration	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
Headache Days	7 days after ED visit	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