Dexamethasone for Post Traumatic Headache

May 13, 2026 updated by: Montefiore Medical Center

A Randomized Study of Dexamethasone as Adjuvant Therapy for Acute Post-traumatic Headache

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • The Bronx, New York, United States, 10467
        • Montefiore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexamethasone
Dexamethasone 10mg IV + metoclopramide 10mg IV
Drug: Dexamethasone
Dexamethasone 10mg IV
Drug: Metoclopramide 10mg
Metoclopramide 10mg IV
Placebo Comparator: Placebo
Placebo IV + metoclopramide 10mg IV
Drug: Metoclopramide 10mg
Metoclopramide 10mg IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Moderate or Severe Headache After Emergency Department (ED) Discharge
Time Frame: From ED discharge to 48-hours following discharge from the ED, up to 2 days total
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.
From ED discharge to 48-hours following discharge from the ED, up to 2 days total

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained Headache Relief
Time Frame: 48 hours after administration of study medication
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.
48 hours after administration of study medication
Post Concussive Symptoms
Time Frame: 48 hours after ED discharge, up to 2 days total
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.
48 hours after ED discharge, up to 2 days total
Post Concussive Symptoms
Time Frame: 7 days after ED discharge, up to 7 days total
Post concussive symptoms at 7 days 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 of greater severity of post-concussive symptoms. Results will be summarized by study arm using basic descriptive statistics.
7 days after ED discharge, up to 7 days total
Use of Rescue Medication in the ED
Time Frame: Duration of ED admission, less than 1 day
Use of rescue medication will be defined as the number of patients administered any analgesic medication or headache abortive medication while in the ED. The number of patients who used rescue medication while in the ED will be summarized by study arm.
Duration of ED admission, less than 1 day

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Days With Headache During the Week After ED Discharge
Time Frame: Up to 1 week after ED discharge, up to 7 days total
The mean number of days with headache during the 1-week period following discharge will be summarized by study arm using basic descriptive statistics
Up to 1 week after ED discharge, up to 7 days total

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Collaborators

National Center for Advancing Translational Sciences (NCATS)

Investigators

  • Principal Investigator: Benjamin Friedman, MD, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2021

Primary Completion (Actual)

November 17, 2024

Study Completion (Actual)

December 22, 2024

Study Registration Dates

First Submitted

March 11, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (Actual)

March 16, 2021

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-12625
  • UL1TR001073 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The de-identified dataset will be made available to clinical researchers upon approval of the analytic plan. Requests should be made to the corresponding author.

IPD Sharing Time Frame

Upon approval of the analytic plan.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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