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Prophylaxis Against Metoclopramide-Induced Akathisia

Primary Purpose

Akathisia

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

midazolam

About this trial

This is an interventional prevention trial for Akathisia focused on measuring metoclopramide, akathisia, midazolam, diphenhydramine, metoclopramide induced akathisia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

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

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

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Prophylaxis Against Metoclopramide-Induced Akathisia

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