Prophylaxis Against Metoclopramide-Induced Akathisia

NCT ID: NCT01051271

Last Updated: 2010-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2009-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

diphenhydramine

Group Type: ACTIVE_COMPARATOR

midazolam

Intervention Type: DRUG

midazolam 1.5 mg

saline

Group Type: PLACEBO_COMPARATOR

midazolam

Intervention Type: DRUG

midazolam 1.5 mg

Interventions

midazolam

midazolam 1.5 mg

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Other Identifiers

PAU-200/1563

Identifier Type: -

Identifier Source: org_study_id