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

Tracking Information
First Received Date ^ICMJE	January 15, 2010
Last Updated Date	January 15, 2010
Start Date ^ICMJE	July 2009
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 15, 2010)	akathisia and sedation scores [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Prophylaxis Against Metoclopramide-Induced Akathisia
Official Title ^ICMJE	Not Provided
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Akathisia
Intervention ^ICMJE	Drug: midazolam midazolam 1.5 mg
Study Arm (s)	Active Comparator: diphenhydramine Intervention: Drug: midazolam Placebo Comparator: saline Intervention: Drug: midazolam
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	225
Completion Date	November 2009
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01051271
Other Study ID Numbers ^ICMJE	PAU-200/1563
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Pamukkale University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Pamukkale University
Verification Date	July 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top