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OpenTrials
Completed

NCT Number: NCT03220958

Metoclopramide for Post Traumatic Headache

Nearly 1.5 million patients present to US emergency departments annually following head trauma. Headache is a frequent symptom of victims of head trauma. The purpose of this study is to see if an intravenous medication called metoclopramide can improve the symptoms of 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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Montefiore Medical Center

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

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, 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.

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 MAO inhibitors, and use of anti-rejection transplant medications.

Treatment and study plan

Metoclopramide

Drug

Metoclopramide 20mg

diphenhydramine

Drug

Diphenhydramine 25mg

normal saline

Drug

100ml normal saline

Primary outcomes

  1. 0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable

    Time frame: 1 hour after medication administration

    Improvement in this 0 to 10 verbal rating scale

Secondary outcomes

  1. Sustained Headache Relief

    Time frame: 48 hours after medication administration

    Achieving a headache intensity of mild or none in the ED without use of rescue medication and maintaining a level of mild or none. Participants rate their headache as none, mild, moderate, or severe

  2. Headache Days

    Time frame: 7 days after ED visit

    Number of days with any headache. Participants report the actual number of days they experienced headache. A "day" begins when they awake for the beginning of daily activities and ends when they go to sleep after completion of daily activities

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

A Randomized Placebo Controlled Trial of IV Metoclopramide for Acute Post-traumatic Headache

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 18, 2017
Registry last updated
Nov 9, 2021

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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