Efficacy and Akathisia Incidence of Slow Infusion Metoclopramide

NCT01069536 | Completed

• 1 other identifier: PAU-200/030-0515
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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. 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

Akathisia; Nausea

Keywords

metoclopramide; akathisia; nausea; vomiting; antiemetic; improvement of nausea

Outcome Measures

Primary Outcomes (1)

• akathisia and nausea scores

Study Arms (2)

2 minutes bolus infusion

ACTIVE COMPARATOR

Drug: metoclopramide 10 mg

15 minutes slow infusion

ACTIVE COMPARATOR

Drug: metoclopramide 10 mg

Interventions

metoclopramide 10 mg DRUG

15 minutes slow infusion; 2 minutes bolus infusion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

MeSH Terms

Conditions

Psychomotor Agitation; Nausea; Vomiting

Interventions

Metoclopramide

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 16, 2010
• First Posted: February 17, 2010
• Study Start: March 1, 2007
• Primary Completion: March 1, 2007
• Study Completion: May 1, 2008
• Last Updated: February 17, 2010

Record last verified: 2007-03