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The Montefiore Metoclopramide Study

NCT ID: NCT00475306

Last Updated: 2012-12-31

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

289 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Nausea Extrapyramidal Symptoms

Keywords

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Metoclopramide Nausea Akathisia Emergency department

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Metoclopramide 20+diphenhydramine

Metoclopramide 20 mg + diphenhydramine, delivered intravenously over 15 minutes

Group Type ACTIVE_COMPARATOR

Diphenhydramine 25 mg

Intervention Type DRUG

used for prophylaxis against akathisia

Metoclopramide 20 mg

Intervention Type DRUG

Metoclopramide 20 mg

Metoclopramide 20+placebo

Metoclopramide 20 mg + placebo, delivered intravenously over 15 minutes

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

placebo

Metoclopramide 20 mg

Intervention Type DRUG

Metoclopramide 20 mg

Metoclopramide 10 + placebo

Metoclopramide 10mg + placebo, delivered intravenously over 15 minutes

Group Type ACTIVE_COMPARATOR

metoclopramide 10 mg

Intervention Type DRUG

an anti-emetic medication

Placebo

Intervention Type DRUG

placebo

Metoclopramide 10+diphenhydramine

Metoclopramide 10 mg + diphenhydramine 25 mg, delivered intravenously over 15 minutes

Group Type ACTIVE_COMPARATOR

metoclopramide 10 mg

Intervention Type DRUG

an anti-emetic medication

Diphenhydramine 25 mg

Intervention Type DRUG

used for prophylaxis against akathisia

Interventions

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metoclopramide 10 mg

an anti-emetic medication

Intervention Type DRUG

Diphenhydramine 25 mg

used for prophylaxis against akathisia

Intervention Type DRUG

Placebo

placebo

Intervention Type DRUG

Metoclopramide 20 mg

Metoclopramide 20 mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Benjamin Friedman

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Benjamin W Friedman, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Brooke Bender, MD

Role: STUDY_DIRECTOR

Albert Einstein College of Medicine

Locations

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Montefiore Medical Center

The Bronx, New York, United States

Site Status

Countries

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United States

Other Identifiers

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07-01-005

Identifier Type: -

Identifier Source: org_study_id