Efficacy and Akathisia Incidence of Slow Infusion Metoclopramide

Nausea Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01069536
• Other study ID #: PAU-200/030-0515
• Status: Completed
• Phase: N/A
• First received: February 16, 2010
• Last updated: February 16, 2010
• Start date: March 2007
• Est. completion date: May 2008

Study information

• Verified date: March 2007
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pamukkale University Ethical Committee Denizli:TURKEY
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: May 2008
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Akathisia
• Nausea

Intervention

Drug:
• metoclopramide 10 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	akathisia and nausea scores			Yes