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Completed

NCT Number: NCT04799015

Dexamethasone for Post Traumatic Headache

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

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Key information

Conditions

Post-Traumatic Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Nervous System Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Montefiore

The Bronx, New York, 10467, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Dexamethasone 10mg IV

Metoclopramide 10mg

Drug

Metoclopramide 10mg IV

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 16, 2021
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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