Efficacy and Akathisia Incidence of Slow Infusion Metoclopramide

This study has been completed.
Sponsor:
Information provided by:
Pamukkale University
ClinicalTrials.gov Identifier:
NCT01069536
First received: February 16, 2010
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Akathisia
Nausea
Drug: metoclopramide 10 mg

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

Resource links provided by NLM:


Further study details as provided by Pamukkale University:

Primary Outcome Measures:
  • akathisia and nausea scores [ Designated as safety issue: Yes ]

Enrollment: 140
Study Start Date: March 2007
Study Completion Date: May 2008
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2 minutes bolus infusion Drug: metoclopramide 10 mg
Active Comparator: 15 minutes slow infusion Drug: metoclopramide 10 mg

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01069536     History of Changes
Other Study ID Numbers: PAU-200/030-0515
Study First Received: February 16, 2010
Last Updated: February 16, 2010
Health Authority: Pamukkale University Ethical Committee Denizli:TURKEY

Keywords provided by Pamukkale University:
metoclopramide
akathisia
nausea
vomiting
antiemetic
improvement of nausea

Additional relevant MeSH terms:
Nausea
Psychomotor Agitation
Signs and Symptoms, Digestive
Signs and Symptoms
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Metoclopramide
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014