Prophylaxis Against Metoclopramide-Induced Akathisia

Pamukkale University

Status

Completed

Conditions

Akathisia

Treatments

Drug: midazolam

Study type

Interventional

Funder types

Other

Identifiers

NCT01051271

PAU-200/1563

Details and patient eligibility

About

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.

Enrollment

225 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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