Efficacy and Akathisia Incidence of Slow Infusion Metoclopramide

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-05-31

Brief Summary

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Study Objective:

The purpose of this study is to compare the effects of metoclopramide administration in bolus versus slow infusion medications in ED patients complaining of nausea for the determination of the therapeutic effect and prevention of akathisia.

Methods:

This was a prospective, randomized, double-blind trial. The investigation was held between 01 March 2007 and 01 May 2008, in the Emergency Department of Pamukkale University Faculty of Medicine. The patients with moderate to severe nausea randomized and divided into two groups as for the previously planned administration type of drug. Ten mg metoclopramide was administered in one group with slow infusion (SIG) in 15 minutes, via 2 minutes bolus infusion (BIG) into the other group. Whole procedure was observed, akathisia and nausea scores and vital changes were recorded.

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Detailed Description

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Conditions

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Akathisia Nausea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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2 minutes bolus infusion

Group Type ACTIVE_COMPARATOR

metoclopramide 10 mg

Intervention Type DRUG

15 minutes slow infusion

Group Type ACTIVE_COMPARATOR

metoclopramide 10 mg

Intervention Type DRUG

Interventions

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metoclopramide 10 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients 18 through 65 years of age and 50-90 kg of weight who presented to the ED with primary or secondary complaints of moderate to severe nausea who not use of commonly accepted antiemetic within the previous 24 hours were eligible for this study.
* Their peripheral oxygen saturation level was 90% or over while respirating room air and free of any respiratory problems.

Exclusion Criteria

* Patients with mild symptoms of nausea
* Altered mental status
* Abnormal vital signs
* Any known allergy to the metoclopramide
* Previously enrolled in the study
* Known renal failure or insufficiency
* GIS hemorrhage, ileus and/or perforation
* Women who were pregnant and lactating
* Those with a history of epilepsy
* Admitted to the ED due to acute psychiatric symptoms
* Restless legs syndrome
* Parkinson
* Organic brain disease
* Phaeochromocytoma
* Patient with alcohol
* Anticholinergic, sedative, hypnotic, trankilizan, digoxin, cimetidine, tetracycline and levo-dopa use
* Presence of severe agitation akathisia can not be evaluated and uncooperative individuals.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No