Prophylaxis Against Metoclopramide-Induced Akathisia

NCT01051271 | Completed

• 1 other identifier: PAU-200/1563
• Study Type: interventional
• Target: 225
• Locations: 0 countries
• Sites: N/A

Brief Summary

ABSTRACT Study Objective: To compare the effects of midazolam and diphenhydramine for the prevention of metoclopramide induced akathisia. Methods: This randomized, double-blind and controlled trial aimed to investigate co-administered midazolam versus diphenhydramine in the prophylaxis of metoclopramide induced akathisia. Patients 18 through 65 years of age who presented to the ED with primary or secondary complaints of nausea and/or moderate to severe vascular type headache were eligible for this study. Patients were randomized to one of the fallowing three groups: (1) metoclopramide 10 mg + midazolam 1.5 mg (2) metoclopramide 10 mg + diphenhydramine 20 mg (3) metoclopramide 10 mg + placebo. Metoclopramide was administered as a 2 minutes bolus infusion. Midazolam, diphenhydramine and normal saline solution administered as a 15 minutes slow infusion. Whole procedure was observed, akathisia and sedation scores and vital changes were recorded.

Conditions

Akathisia

Keywords

metoclopramide; akathisia; midazolam; diphenhydramine; metoclopramide induced akathisia

Outcome Measures

Primary Outcomes (1)

• akathisia and sedation scores

Study Arms (2)

diphenhydramine

ACTIVE COMPARATOR

Drug: midazolam

saline

PLACEBO COMPARATOR

Drug: midazolam

Interventions

midazolam DRUG

midazolam 1.5 mg

diphenhydramine; saline

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 nausea and/or moderate to severe vascular type headache were eligible for this study.

You may not qualify if:

• Patients who had liver and renal insufficiency
• Electrolyte imbalance
• Acute respiratory symptoms
• Chronic obstructive pulmonary disease
• Blood pressure less than 90/60 mmHg
• Uncooperative individuals
• Pregnant or lactating
• Pre-existing motor disorder
• Restless legs syndrome-parkinson's disease
• Organic brain disorder, (dementia etc.), epilepsy
• Admitted to the ED due to acute psychiatric symptoms
• Deprived mental status
• Advanced hearing loss
• Malnutrition
• Acute asthma attack

Sponsors & Collaborators

• Pamukkale University: lead

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

Midazolam

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

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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: January 15, 2010
• First Posted: January 18, 2010
• Study Start: July 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: November 1, 2009
• Last Updated: January 18, 2010

Record last verified: 2009-07