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Clinical Trials/NCT00475306
NCT00475306CompletedPhase 4

A Randomized, Facorial Design Study to Optimize the Dose of Parenteral Metoclopramide

Montefiore Medical Center1 site in 1 country289 target enrollmentStarted: May 2007Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
289
Locations
1
Primary Endpoint
Nausea Scale

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to 65 Years (Adult, Older Adult)
Sex
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

Arms & Interventions

Metoclopramide 20+placebo

Active Comparator

Metoclopramide 20 mg + placebo, delivered intravenously over 15 minutes

Intervention: Metoclopramide 20 mg (Drug)

Metoclopramide 20+diphenhydramine

Active Comparator

Metoclopramide 20 mg + diphenhydramine, delivered intravenously over 15 minutes

Intervention: Diphenhydramine 25 mg (Drug)

Metoclopramide 20+diphenhydramine

Active Comparator

Metoclopramide 20 mg + diphenhydramine, delivered intravenously over 15 minutes

Intervention: Metoclopramide 20 mg (Drug)

Metoclopramide 20+placebo

Active Comparator

Metoclopramide 20 mg + placebo, delivered intravenously over 15 minutes

Intervention: Placebo (Drug)

Metoclopramide 10 + placebo

Active Comparator

Metoclopramide 10mg + placebo, delivered intravenously over 15 minutes

Intervention: metoclopramide 10 mg (Drug)

Metoclopramide 10 + placebo

Active Comparator

Metoclopramide 10mg + placebo, delivered intravenously over 15 minutes

Intervention: Placebo (Drug)

Metoclopramide 10+diphenhydramine

Active Comparator

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

Intervention: metoclopramide 10 mg (Drug)

Metoclopramide 10+diphenhydramine

Active Comparator

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

Intervention: Diphenhydramine 25 mg (Drug)

Outcomes

Primary Outcomes

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 Outcomes

  • Number of Participants With Akathisia(60 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Benjamin Friedman

Associate professor

Montefiore Medical Center

Study Sites (1)

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