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The Montefiore Metoclopramide Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Benjamin Friedman, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00475306
First received: May 16, 2007
Last updated: November 28, 2012
Last verified: November 2012
History of Changes
  Purpose

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
Nausea
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Nausea Scale [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
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
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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00475306

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

No publications provided

Responsible Party: Benjamin Friedman, Associate professor, Montefiore Medical Center
ClinicalTrials.gov 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
Health Authority: United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
Metoclopramide
Nausea
Akathisia
Emergency department

Additional relevant MeSH terms:
Nausea
Basal Ganglia Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Diphenhydramine
Metoclopramide
Promethazine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Allergic Agents
Anesthetics, Local
Anesthetics
Sensory System Agents
Antipruritics

ClinicalTrials.gov processed this record on May 19, 2013