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

January 15, 2010
January 15, 2010
July 2009
July 2009   (final data collection date for primary outcome measure)
akathisia and sedation scores [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
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Prophylaxis Against Metoclopramide-Induced Akathisia
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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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Akathisia
Drug: midazolam
midazolam 1.5 mg
  • Active Comparator: diphenhydramine
    Intervention: Drug: midazolam
  • Placebo Comparator: saline
    Intervention: Drug: midazolam
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
225
November 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT01051271
PAU-200/1563
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Pamukkale University
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Pamukkale University
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP