Prophylaxis Against Metoclopramide-Induced Akathisia

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

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
Serious physical illness, especially glaucoma, prostatic hypertrophy, or cardiac disease
Had a contraindication to anticholinergic medications
Within 3 days of study entry patients who had taken an antiemetic antihistaminic, antipsychotic, antispasmodic, alpha-blocker, or Ca++2-channel blocker, or within 2 weeks of study entry patients who had taken an antidepressant, barbiturate, benzodiazepine, other sedative/hypnotic, opioid, lithium, or illicit sympathomimetic agent were excluded

Treatment and study plan

midazolam

Drug

midazolam 1.5 mg

Primary outcomes

akathisia and sedation scores

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Jan 18, 2010
Registry last updated: Jan 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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