Prophylaxis Against Metoclopramide-Induced Akathisia
Status:
Completed
Trial end date:
2009-11-01
Target enrollment:
Participant gender:
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.