Metoclopramide for Post Traumatic Headache

A Randomized Placebo Controlled Trial of IV Metoclopramide for Acute 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.

Study Overview

• Status: Completed
• Conditions: Post-Traumatic Headache
• Intervention / Treatment: Drug: Metoclopramide; Drug: Diphenhydramine; Drug: Normal saline

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable	Improvement in this 0 to 10 verbal rating scale	1 hour after medication administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustained Headache Relief	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	48 hours after medication administration
Headache Days	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	7 days after ED visit

Collaborators and Investigators

• Sponsor: Montefiore Medical Center

Publications and helpful links

General Publications

• Friedman BW, Irizarry E, Cain D, Caradonna A, Minen MT, Solorzano C, Zias E, Zybert D, McGregor M, Bijur PE, Gallagher EJ. Randomized Study of Metoclopramide Plus Diphenhydramine for Acute Posttraumatic Headache. Neurology. 2021 May 4;96(18):e2323-e2331. doi: 10.1212/WNL.0000000000011822. Epub 2021 Mar 24.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2017
• Primary Completion (ACTUAL): April 1, 2020
• Study Completion (ACTUAL): April 1, 2020

Study Registration Dates

• First Submitted: April 19, 2017
• First Submitted That Met QC Criteria: July 15, 2017
• First Posted (ACTUAL): July 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 8, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Traumatic Headache; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Dopamine Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Hypnotics and Sedatives; Anesthetics, Local; Anti-Allergic Agents; Sleep Aids, Pharmaceutical; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Diphenhydramine; Promethazine; Metoclopramide
• Other Study ID Numbers: 2017-7898

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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