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Metoclopramide for Post Traumatic Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03220958
Recruitment Status : Completed
First Posted : July 18, 2017
Results First Posted : November 9, 2021
Last Update Posted : November 9, 2021
Sponsor:
Information provided by (Responsible Party):
Benjamin W. Friedman, MD, Montefiore Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Post-Traumatic Headache Drug: Metoclopramide Drug: Diphenhydramine Drug: Normal saline Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Placebo Controlled Trial of IV Metoclopramide for Acute Post-traumatic Headache
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arms and Interventions
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Arm Intervention/treatment
Experimental: Metoclopramide
Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip
 Drug: Metoclopramide
Metoclopramide 20mg

Drug: Diphenhydramine
Diphenhydramine 25mg

Drug: Normal saline
100ml normal saline
Placebo Comparator: Placebo
Normal saline, administered as an intravenous drip
 Drug: Normal saline
100ml normal saline


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03220958


Locations
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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
  Study Documents (Full-Text)

Documents provided by Benjamin W. Friedman, MD, Montefiore Medical Center:
Study Protocol and Statistical Analysis Plan  [PDF] July 11, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Benjamin W. Friedman, MD, Associate Professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03220958    
Other Study ID Numbers: 2017-7898
First Posted: July 18, 2017    Key Record Dates
Results First Posted: November 9, 2021
Last Update Posted: November 9, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: Yes
Additional relevant MeSH terms:
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Post-Traumatic Headache
Headache
Pain
Neurologic Manifestations
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Diphenhydramine
Promethazine
Metoclopramide
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
 Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Antipruritics