Metoclopramide for Post-Traumatic Headache. A Pilot Study

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 2; Phase 1

Conditions: Post-Traumatic Headache

Treatments: Drug: Metoclopramide; Drug: Diphenhydramine

Study type: Interventional

Funder types: Other

Identifiers

NCT03056352

2017-7511

Details and patient eligibility

About

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

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Metoclopramide

Experimental group

Description:

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

Treatment:

Drug: Diphenhydramine

Drug: Metoclopramide