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Prophylaxis Against Metoclopramide-Induced Akathisia

This study has been completed.
Sponsor:
Information provided by:
Pamukkale University
ClinicalTrials.gov Identifier:
NCT01051271
First received: January 15, 2010
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Akathisia
 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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov 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
akathisia
midazolam
diphenhydramine
metoclopramide induced akathisia

Additional relevant MeSH terms:
Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Diphenhydramine
Metoclopramide
Promethazine
Midazolam
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Allergic Agents
Anesthetics, Local
Anesthetics
Sensory System Agents

ClinicalTrials.gov processed this record on May 22, 2013