Prophylaxis Against Metoclopramide-Induced Akathisia

Study Overview
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Brief Summary
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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.

Conditions
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Akathisia

Intervention / Treatment
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* Drug: midazolam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: diphenhydramine<br> | Drug: midazolam<br>* midazolam 1.5 mg<br>|
| Placebo Comparator: saline<br> | Drug: midazolam<br>* midazolam 1.5 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| akathisia and sedation scores |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metoclopramide, akathisia, midazolam, diphenhydramine, metoclopramide induced akathisia