Dexamethasone for Post Traumatic Headache

Montefiore Medical Center162 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

162

Conditions

Post-Traumatic Headache

Interventions

DexamethasoneDRUG

Dexamethasone 10mg IV

Metoclopramide 10mgDRUG

Metoclopramide 10mg IV

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: Meet International Classification of Headache Disorders (3rd edition) 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 Monoamine oxidase (MAO) inhibitors, and use of anti-rejection transplant medications

Locations (1)

Montefiore

The Bronx, New York, United States

Outcomes

Primary Outcomes

Frequency of Moderate or Severe Headache After Emergency Department (ED) Discharge

Headache intensity will be rated based on the International Headache Society (IHS) 4-point scale. Using this scale participants will verbalize whether their headache intensity is "Severe," "Moderate," "Mild," or "None." The percentage of patients reporting a headache intensity level of either "Moderate" or "Severe" will be grouped and summarized by study arm. The number/percentage of patients reporting a headache intensity level of "Mild" or "None" will also be grouped and summarized by study arm. Between-group difference along with 95% confidence intervals will be reported. Patients who use an analgesic or abortive headache medication during the 48-hour period will be considered an outcome failure.

Time frame: From ED discharge to 48-hours following discharge from the ED, up to 2 days total

Secondary Outcomes

Sustained Headache Relief

Sustained headache pain relief will be defined as the number of patients achieving a headache intensity of "mild" or "none" after administration of study medication and who maintain that level for 48 hours without the use of rescue medication. The percentage of patients reporting a headache intensity level of either "mild" or "none" will be considered to have achieved and maintained sustained headache relief and will be summarized by study arm.

Time frame: 48 hours after administration of study medication

Post Concussive Symptoms

Post concussive symptoms at 48 hours will be assessed using the Sport Concussion Assessment Tool (SCAT) Post Concussion Symptom Scale (PCSS). Using the validated SCAT PCSS patients rate the severity of 22 concussive symptoms on a 7-point Likert scale ranging from 0 ("none") to 6 ("severe") yielding an overall possible scoring range of 0-132. Higher SCAT PCSS scores are indicative greater severity of post-concussive symptoms. Results will be summarized by study arm using basic descriptive statistics.

Time frame: 48 hours after ED discharge, up to 2 days total

Post Concussive Symptoms

Data from ClinicalTrials.gov

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