Dexamethasone for Post Traumatic Headache

Sponsor
Montefiore Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04799015
Collaborator
(none)
162
Enrollment
1
Location
2
Arms
35.2
Anticipated Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
162 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized Study of Dexamethasone as Adjuvant Therapy for Acute Post-traumatic Headache
Actual Study Start Date :
Feb 24, 2021
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. Moderate or Severe headache after Emergency Department discharge [48 hours]

    Rating headache moderate or severe on a scale of severe, moderate, mild, or none

Secondary Outcome Measures

  1. Sustained headache relief [48 hours]

    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.

  2. Post concussive symptom scale [48 hours and 7 days after emergency department discharge]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1MontefioreBronxNew YorkUnited States10467

Sponsors and Collaborators

  • Montefiore Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT04799015
Other Study ID Numbers:
  • 2020-12625
First Posted:
Mar 16, 2021
Last Update Posted:
Feb 17, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 17, 2022