Efficacy and Akathisia Incidence of Slow Infusion Metoclopramide

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01069536
Recruitment Status : Completed
First Posted : February 17, 2010
Last Update Posted : February 17, 2010
Information provided by:
Pamukkale University

Brief 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.


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.

Condition or disease Intervention/treatment Phase
Akathisia Nausea Drug: metoclopramide 10 mg Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : March 2007
Actual Primary Completion Date : March 2007
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 2 minutes bolus infusion Drug: metoclopramide 10 mg
Active Comparator: 15 minutes slow infusion Drug: metoclopramide 10 mg

Primary Outcome Measures :
  1. akathisia and nausea scores

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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. Identifier: NCT01069536     History of Changes
Other Study ID Numbers: PAU-200/030-0515
First Posted: February 17, 2010    Key Record Dates
Last Update Posted: February 17, 2010
Last Verified: March 2007

Keywords provided by Pamukkale University:
improvement of nausea

Additional relevant MeSH terms:
Psychomotor Agitation
Signs and Symptoms, Digestive
Signs and Symptoms
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action