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The Montefiore Metoclopramide Study

This study has been completed.
Information provided by (Responsible Party):
Benjamin Friedman, Montefiore Medical Center Identifier:
First received: May 16, 2007
Last updated: November 28, 2012
Last verified: November 2012
Metoclopramide is a dopamine antagonist frequently used for the treatment of nausea, vomiting, and migraine headaches in Emergency Departments. However, little research has focused on the optimal dose of metoclopramide for treatment of nausea in the emergency department. We propose a randomized, double-blind, placebo controlled trial to investigate the optimal dose of metoclopramide for treatment of nausea.

Condition Intervention Phase
Extrapyramidal Symptoms
Drug: metoclopramide 10 mg
Drug: Diphenhydramine 25 mg
Drug: Placebo
Drug: Metoclopramide 20 mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Facorial Design Study to Optimize the Dose of Parenteral Metoclopramide

Resource links provided by NLM:

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Nausea Scale [ Time Frame: 60 minutes ]
    Patients were asked to report their level of nausea on a scale for 0 to 10, with 0 representing no nausea and 10 the worst nausea imaginable

Secondary Outcome Measures:
  • Number of Participants With Akathisia [ Time Frame: 60 minutes ]
    The akathisia outcome was reported as follows: Either development of akathisia as measured using the Short Akathisia Instrument (Vinson DR. Journal of Emergency Medicine. 2006; 31:139-145)or use of rescue medication for treatment of akathisia.The short akathisia instrument briefly measures subjective and objective restlessness.

Enrollment: 289
Study Start Date: May 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metoclopramide 20+diphenhydramine
Metoclopramide 20 mg + diphenhydramine, delivered intravenously over 15 minutes
Drug: Diphenhydramine 25 mg
used for prophylaxis against akathisia
Drug: Metoclopramide 20 mg
Metoclopramide 20 mg
Active Comparator: Metoclopramide 20+placebo
Metoclopramide 20 mg + placebo, delivered intravenously over 15 minutes
Drug: Placebo
Drug: Metoclopramide 20 mg
Metoclopramide 20 mg
Active Comparator: Metoclopramide 10 + placebo
Metoclopramide 10mg + placebo, delivered intravenously over 15 minutes
Drug: metoclopramide 10 mg
an anti-emetic medication
Drug: Placebo
Active Comparator: Metoclopramide 10+diphenhydramine
Metoclopramide 10 mg + diphenhydramine 25 mg, delivered intravenously over 15 minutes
Drug: metoclopramide 10 mg
an anti-emetic medication
Drug: Diphenhydramine 25 mg
used for prophylaxis against akathisia

Detailed Description:

The most effective dose of metoclopramide for treatment of nausea in the emergency department setting has not been thoroughly investigated. One pilot study among emergency department patients in Australia found no statistical difference between 10 mg and 0.4 milligrams/kilogram; another investigation suggests that the anti-emetic effect of 10 milligrams of metoclopramide is no more effective than placebo. In contrast, investigations focusing on chemotherapy patients and post-operative patients suggest that higher dosage metoclopramide is more effective in treating nausea and vomiting. This emergency department study will compare the anti-emetic efficacy of 10 milligrams and 20 milligrams of metoclopramide by using the visual analog scale.

In addition to evaluation of dose, we will evaluate one of the most common side affects of metoclopramide, akathisia. Akathisia is characterized by a subjective component of restlessness and an objective component in the form of the inability to remain motionless. Anti-cholinergic medications are known to reduce extrapyramidal symptoms such as akathisia when dopamine function is impaired in the basal ganglia. In fact, the use of diphenhydramine has been shown to reduce the incidence of akathisia in patients receiving a different anti-emetic, prochlorperazine. However, no research has focused on the use of anti-cholinergic medications to reduce metoclopramide induced akathisia. This investigation will assess the use of 25 mg of diphenhydramine in preventing metoclopramide induced akathisia in ED patients being treated for nausea/vomiting.


Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • primary or secondary complaints of nausea/vomiting
  • age 21-65

Exclusion Criteria:

  • pregnancy
  • use of anti-histamine or dopamine antagonist as outpatient and/or within last 24 hours of presentation
  • previous adverse reaction to study medications
  • use of opioid medications prior to study start time within that ED visit
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Please refer to this study by its identifier: NCT00475306

United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
Montefiore Medical Center
Principal Investigator: Benjamin W Friedman, MD Montefiore Medical Center
Study Director: Brooke Bender, MD Albert Einstein College of Medicine, Inc.
  More Information

Responsible Party: Benjamin Friedman, Associate professor, Montefiore Medical Center Identifier: NCT00475306     History of Changes
Other Study ID Numbers: 07-01-005
Study First Received: May 16, 2007
Results First Received: July 11, 2011
Last Updated: November 28, 2012

Keywords provided by Montefiore Medical Center:
Emergency department

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anti-Allergic Agents
Dermatologic Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents processed this record on April 26, 2017