Prophylaxis Against Metoclopramide-Induced Akathisia

This study has been completed.
Information provided by:
Pamukkale University Identifier:
First received: January 15, 2010
Last updated: NA
Last verified: July 2009
History: No changes posted


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 Intervention
Drug: midazolam

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by Pamukkale University:

Primary Outcome Measures:
  • akathisia and sedation scores [ Designated as safety issue: Yes ]

Enrollment: 225
Study Start Date: July 2009
Study Completion Date: November 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: diphenhydramine Drug: midazolam
midazolam 1.5 mg
Placebo Comparator: saline Drug: midazolam
midazolam 1.5 mg


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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No Contacts or Locations Provided
  More Information Identifier: NCT01051271     History of Changes
Other Study ID Numbers: PAU-200/1563 
Study First Received: January 15, 2010
Last Updated: January 15, 2010
Health Authority: Pamukkale University Denizli :TURKEY

Keywords provided by Pamukkale University:
metoclopramide induced akathisia

Additional relevant MeSH terms:
Adjuvants, Anesthesia
Anesthetics, General
Anesthetics, Intravenous
Anesthetics, Local
Anti-Allergic Agents
Anti-Anxiety Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
GABA Agents
GABA Modulators
Gastrointestinal Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents processed this record on April 27, 2016