Prophylaxis Against Metoclopramide-Induced Akathisia

Akathisia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01051271
• Other study ID #: PAU-200/1563
• Status: Completed
• Phase: N/A
• First received: January 15, 2010
• Last updated: January 15, 2010
• Start date: July 2009
• Est. completion date: November 2009

Study information

• Verified date: July 2009
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pamukkale University Denizli :TURKEY
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: November 2009
• Est. primary completion date: July 2009
• 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 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

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

Intervention

Drug:
• midazolam
midazolam 1.5 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 sedation scores			Yes