Efficacy and Akathisia Incidence of Slow Infusion Metoclopramide

Study Overview
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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.

Conditions
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Akathisia, Nausea

Intervention / Treatment
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* Drug: metoclopramide 10 mg


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2 minutes bolus infusion<br> | Drug: metoclopramide 10 mg<br> <br> |
| Active Comparator: 15 minutes slow infusion<br> | Drug: metoclopramide 10 mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| akathisia and nausea scores |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metoclopramide, akathisia, nausea, vomiting, antiemetic, improvement of nausea