Dexamethasone for Post Traumatic Headache

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 4

Conditions: Post-Traumatic Headache

Treatments: Drug: Metoclopramide 10mg; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT04799015

2020-12625

Details and patient eligibility

About

This is a randomized study of intravenous metoclopramide + intravenous dexamethasone versus intravenous metoclopramide for patients with acute post-traumatic headache.

Enrollment: 162 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Meet International Classification of Headache Disorders criteria for acute post-traumatic headache 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 (e.g., migraine or tension-type headache)
• The headache must be rated as moderate or severe in intensity at the time of initial evaluation

Exclusion criteria

• More than ten days have elapsed since the head trauma
• Headache has already been treated with an anti-dopaminergic medication
• Medication allergies
• Contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of anti-rejection transplant medications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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162 participants in 2 patient groups, including a placebo group

Dexamethasone

Experimental group

Description:

Dexamethasone 10mg IV + metoclopramide 10mg IV

Treatment:

Drug: Dexamethasone

Drug: Metoclopramide 10mg

Placebo

Placebo Comparator group

Description:

Placebo IV + metoclopramide 10mg IV

Treatment:

Drug: Metoclopramide 10mg