Efficacy and Akathisia Incidence of Slow Infusion Metoclopramide

Pamukkale University

Status: Completed

Conditions: Nausea; Akathisia

Treatments: Drug: metoclopramide 10 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01069536

PAU-200/030-0515

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups

2 minutes bolus infusion

Active Comparator group

Treatment:

Drug: metoclopramide 10 mg

15 minutes slow infusion

Active Comparator group

Treatment:

Drug: metoclopramide 10 mg