Prophylaxis Against Metoclopramide-Induced Akathisia
Primary Purpose
Akathisia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
midazolam
Sponsored by
About this trial
This is an interventional prevention trial for Akathisia focused on measuring metoclopramide, akathisia, midazolam, diphenhydramine, metoclopramide induced akathisia
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
diphenhydramine
saline
Arm Description
Outcomes
Primary Outcome Measures
akathisia and sedation scores
Secondary Outcome Measures
Full Information
NCT ID
NCT01051271
First Posted
January 15, 2010
Last Updated
January 15, 2010
Sponsor
Pamukkale University
1. Study Identification
Unique Protocol Identification Number
NCT01051271
Brief Title
Prophylaxis Against Metoclopramide-Induced Akathisia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pamukkale University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Akathisia
Keywords
metoclopramide, akathisia, midazolam, diphenhydramine, metoclopramide induced akathisia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
225 (Actual)
8. Arms, Groups, and Interventions
Arm Title
diphenhydramine
Arm Type
Active Comparator
Arm Title
saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
midazolam
Intervention Description
midazolam 1.5 mg
Primary Outcome Measure Information:
Title
akathisia and sedation scores
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
Prophylaxis Against Metoclopramide-Induced Akathisia
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