The Montefiore Metoclopramide Study

Phase 4

Completed

Conditions: Nausea
Extrapyramidal Symptoms

Interventions: Drug: Diphenhydramine 25 mg
Drug: Placebo
Drug: metoclopramide 10 mg
Drug: Metoclopramide 20 mg

Registration Number: NCT00475306

Lead Sponsor: Montefiore Medical Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 289

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Metoclopramide 20+diphenhydramine	Diphenhydramine 25 mg	Metoclopramide 20 mg + diphenhydramine, delivered intravenously over 15 minutes
Metoclopramide 20+diphenhydramine	Metoclopramide 20 mg	Metoclopramide 20 mg + diphenhydramine, delivered intravenously over 15 minutes
Metoclopramide 20+placebo	Placebo	Metoclopramide 20 mg + placebo, delivered intravenously over 15 minutes
Metoclopramide 20+placebo	Metoclopramide 20 mg	Metoclopramide 20 mg + placebo, delivered intravenously over 15 minutes
Metoclopramide 10 + placebo	metoclopramide 10 mg	Metoclopramide 10mg + placebo, delivered intravenously over 15 minutes
Metoclopramide 10 + placebo	Placebo	Metoclopramide 10mg + placebo, delivered intravenously over 15 minutes
Metoclopramide 10+diphenhydramine	metoclopramide 10 mg	Metoclopramide 10 mg + diphenhydramine 25 mg, delivered intravenously over 15 minutes
Metoclopramide 10+diphenhydramine	Diphenhydramine 25 mg	Metoclopramide 10 mg + diphenhydramine 25 mg, delivered intravenously over 15 minutes

Primary Outcome Measures

Name	Time	Method
Nausea Scale	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

Name	Time	Method
Number of Participants With Akathisia	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.