Dexamethasone for Post Traumatic Headache

Post-Traumatic Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04799015
• Other study ID #: 2020-12625
• Status: Recruiting
• Phase: Phase 4
• Start date: February 24, 2021
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: Montefiore Medical Center
• Contact: Benjamin Friedman, MD
• Phone: 718-920-6626
• Email: befriedm[@]montefiore.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: October 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Included patients will be adults who meet International Classification of Headache Disorders criteria for acute post-traumatic headache. These are 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 (eg, migraine or tension-type headache)

• The headache must be rated as moderate or severe in intensity at the time of initial evaluation.

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 allergies or contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of anti-rejection transplant medications.

Related Conditions & MeSH terms

• Headache
• Post-Traumatic Headache

Intervention

Drug:
• Dexamethasone
Dexamethasone 10mg IV
• Metoclopramide 10mg
Metoclopramide 10mg IV

Locations

Country	Name	City	State
United States	Montefiore	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Moderate or Severe headache after Emergency Department discharge	Rating headache moderate or severe on a scale of severe, moderate, mild, or none	48 hours
Secondary	Sustained headache relief	Achieving a headache intensity of mild or none in the emergency department without use of rescue medication and maintaining that level for 48 hours without use of rescue medication.	48 hours
Secondary	Post concussive symptom scale	The Sport Concussion Assessment Tool (SCAT) Post Concussion Symptom Scale (PCSS). On this validated instrument, patients rate 22 concussive symptoms on a 0 to 6 scale, with 6 signifying more severe pain	48 hours and 7 days after emergency department discharge