Metoclopramide for Post-Traumatic Headache. A Pilot Study

Overview

Post-traumatic headache is common. We are determining short and longer-term outcomes among patients treated for post-traumatic headache with IV metoclopramide.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 20, 2017

Interventions

  • Drug: Metoclopramide
    • Intravenous medication drip
  • Drug: Diphenhydramine
    • Intravenous medication drip

Arms, Groups and Cohorts

  • Experimental: Metoclopramide
    • Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With Sustained Headache Relief
    • Time Frame: 2 hours thru 48 hours after treatment
    • Sustained headache relief is defined as achieving a headache level of “mild” or “none” within two hours and maintaining a level of “mild” or “none” for 48 hours. Patient self-evaluated pain level is solicited every half hour for two hours in the Emergency Department and then by telephone 48 hours after medication administration.

Secondary Measures

  • Post Concussion Symptoms Assessed by Post-concussive Symptom Scale
    • Time Frame: 7 days
    • The post-concussive symptom scale is a questionnaire administered verbally. The post-concussive symptom ranges from 0 to 132. 0= no post-concussive symptoms. 132= severe post-concussive symptoms.
  • Number of Participants Satisfied With Medication; Assessed by Self-evaluation
    • Time Frame: 48 hours after treatment
    • Satisfaction is measured by a positive response to the question “Would you want to receive the same medication during a subsequent visit for post-traumatic headache?”

Participating in This Clinical Trial

Inclusion Criteria

  • 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, previous history of migraine or tension-type headache) – The headache must be rated as moderate or severe in intensity at the time of initial evaluation. – The plan of the attending emergency physician must include treatment with parenteral metoclopramide. 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 contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of monoamine oxidase inhibitors, and use of anti-rejection transplant medications. Patients will not be excluded for pregnancy or breast-feeding.

Gender Eligibility: All

Per patient

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Montefiore Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Benjamin W. Friedman, MD, Professor – Montefiore Medical Center

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.