Prophylaxis Against Metoclopramide-Induced Akathisia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01051271
Recruitment Status : Completed
First Posted : January 18, 2010
Last Update Posted : January 18, 2010
Information provided by:
Pamukkale University

Brief Summary:


Study Objective:

To compare the effects of midazolam and diphenhydramine for the prevention of metoclopramide induced akathisia.


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.

Condition or disease Intervention/treatment Phase
Akathisia Drug: midazolam Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : July 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: diphenhydramine Drug: midazolam
midazolam 1.5 mg

Placebo Comparator: saline Drug: midazolam
midazolam 1.5 mg

Primary Outcome Measures :
  1. akathisia and sedation scores

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 Identifier: NCT01051271     History of Changes
Other Study ID Numbers: PAU-200/1563
First Posted: January 18, 2010    Key Record Dates
Last Update Posted: January 18, 2010
Last Verified: July 2009

Keywords provided by Pamukkale University:
metoclopramide induced akathisia

Additional relevant MeSH terms:
Psychomotor Agitation
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Autonomic Agents