Prophylaxis Against Metoclopramide-Induced Akathisia

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01051271

Enrollment

225

Registered

2010-01-18

Start date

2009-07-31

Completion date

2009-11-30

Last updated

2010-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Akathisia

Keywords

metoclopramide, akathisia, midazolam, diphenhydramine, metoclopramide induced akathisia

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.

Interventions

DRUGmidazolam

midazolam 1.5 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
akathisia and sedation scores	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026