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Efficacy and Akathisia Incidence of Slow Infusion Metoclopramide

Information source: Pamukkale University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Akathisia; Nausea

Intervention: metoclopramide 10 mg (Drug)

Phase: N/A

Status: Completed

Sponsored by: Pamukkale University

Summary

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.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: akathisia and nausea scores

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Additional Information

Starting date: March 2007
Last updated: February 16, 2010

Page last updated: August 23, 2015

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