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

May 16, 2007
November 28, 2012
May 2007
February 2008   (final data collection date for primary outcome measure)
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
Nausea scale [ Time Frame: 60m ]
Complete list of historical versions of study NCT00475306 on ClinicalTrials.gov Archive Site
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.
Akathisia scale [ Time Frame: 60m ]
Not Provided
Not Provided
 
The Montefiore Metoclopramide Study
A Randomized, Facorial Design Study to Optimize the Dose of Parenteral Metoclopramide

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Nausea
  • Extrapyramidal Symptoms
  • Drug: metoclopramide 10 mg
    an anti-emetic medication
  • Drug: Diphenhydramine 25 mg
    used for prophylaxis against akathisia
  • Drug: Placebo
    placebo
  • Drug: Metoclopramide 20 mg
    Metoclopramide 20 mg
  • Active Comparator: Metoclopramide 20+diphenhydramine
    Metoclopramide 20 mg + diphenhydramine, delivered intravenously over 15 minutes
    Interventions:
    • Drug: Diphenhydramine 25 mg
    • Drug: Metoclopramide 20 mg
  • Active Comparator: Metoclopramide 20+placebo
    Metoclopramide 20 mg + placebo, delivered intravenously over 15 minutes
    Interventions:
    • Drug: Placebo
    • Drug: Metoclopramide 20 mg
  • Active Comparator: Metoclopramide 10 + placebo
    Metoclopramide 10mg + placebo, delivered intravenously over 15 minutes
    Interventions:
    • Drug: metoclopramide 10 mg
    • Drug: Placebo
  • Active Comparator: Metoclopramide 10+diphenhydramine
    Metoclopramide 10 mg + diphenhydramine 25 mg, delivered intravenously over 15 minutes
    Interventions:
    • Drug: metoclopramide 10 mg
    • Drug: Diphenhydramine 25 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
289
February 2008
February 2008   (final data collection date for primary outcome measure)

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
Both
21 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00475306
07-01-005
No
Benjamin Friedman, Montefiore Medical Center
Montefiore Medical Center
Not Provided
Principal Investigator: Benjamin W Friedman, MD Montefiore Medical Center
Study Director: Brooke Bender, MD Albert Einstein College of Medicine of Yeshiva University
Montefiore Medical Center
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP