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Trial registered on ANZCTR


Registration number
ACTRN12607000121460
Ethics application status
Not yet submitted
Date submitted
29/11/2006
Date registered
9/02/2007
Date last updated
9/02/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial of Bolus Versus Fifteen Minute Infusion of Metoclopramide to Determine the Incidence and Severity of Drug Induced Akathisia.
Scientific title
A Randomised Controlled Trial of Bolus Versus Fifteen Minute Infusion of Metoclopramide to Determine the Incidence and Severity of Drug Induced Akathisia.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute drug induced akathisia (DIA) in adult Emergency Department (ED). 1613 0
Condition category
Condition code
Other 1721 1721 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A. Normal saline 10ml bolus over two minutes is placebo and then Metoclopramide Intravenous Infusion (MII): Metoclopramide 20mg in 100ml of Normal Saline as intravenous infusion over 15 minutes, is intervention.

B. Metoclopramide Intravenous Bolus (MIB): Metoclopramide 20mg as 10ml bolus over 2 minutes intravenously, is the control treatment, and an infusion of Normal Saline over 15 minutes, is placebo.
Intervention code [1] 1475 0
Treatment: Drugs
Comparator / control treatment
A. Normal saline 10ml bolus over two minutes is placebo

B. Infusion of Normal Saline over 15 minutes, is placebo.
Control group
Active

Outcomes
Primary outcome [1] 2389 0
The rate of drug induced akathisia (DIA) as measured by a patient derived global outcome measure and the Prince Henry Hospital Akathisia Rating Scale (PHARS).
Timepoint [1] 2389 0
Measured at 15 minutes after infusion, then every 15 minutes for an hour. If akathisia occurs in this time it is a negative outcome.
Secondary outcome [1] 4154 0
The severity of DIA as measured by a patient derived global outcome measure and PHARS.
Timepoint [1] 4154 0
Outcomes measured at fifteen minutes after infusion, then every 15 minutes for one hour.
Secondary outcome [2] 4155 0
The degree of distress resulting from DIA as measured by a patient derived global score.
Timepoint [2] 4155 0
Outcomes measured at fifteen minutes after infusion, then every 15 minutes for one hour.

Eligibility
Key inclusion criteria
Patients receiving metoclopramide in the ED for any indication.
Minimum age
19 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Evidence of pre-existing akathisia or previous DIA, patients who are unstable or too unwell to participate, Parkinson disease, restless leg syndrome, taking of dopamine antagonist drugs such as tricyclic anti-depressants (TCA), antiemetic or antipsychotic in the preceding 24 hours and those in whom akathisia rescue medication would be contra indicated, such as glaucoma or urinary retention. Patients with cognitive impairment or English as a second language.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Pharmacy will receive the randomisation list from the researcher and keep it in a secure place. The clinician enrols a subject and gets their consent. Pharmacy will confirm completed enrolment and consent forms and the subjects are allocated to intervention A or B using the randomisation list. This will ensure that the sequence was concealed until allocation has occurred. Pharmacy will then prepare identical appearing infusion and bolus drugs and placebo labelled A or B in sealed unmarked container and give it to the clinician to administer. The after-hours nurse coordinator will perform this role using pre-prepared pharmacy packs in non-pharmacy hours.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A permute block method will be used to ensure equal number in both intervention groups. This will be done using the Moses-Oakford method for treatment assignment that has been previously described. Group codes of A-MII and B-MIB arbitrary block allocation would be performed to allocate to two intervention groups. A list of random numbers would be obtained from a random number chart. After recording the random numbers a final block order and thus randomisation list would be produced.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects, therapist, and assessor will be blinded
Phase
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1868 0
Hospital
Name [1] 1868 0
Southern Health, Monash Medical Centre
Country [1] 1868 0
Australia
Primary sponsor type
Individual
Name
Dr.Diana Egerton-Warburton
Address
Country
Secondary sponsor category [1] 1685 0
Individual
Name [1] 1685 0
Dr.Kirsty Povey
Address [1] 1685 0
Country [1] 1685 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3477 0
Monash Medical Centre, Southern Health
Ethics committee address [1] 3477 0
Ethics committee country [1] 3477 0
Australia
Date submitted for ethics approval [1] 3477 0
Approval date [1] 3477 0
Ethics approval number [1] 3477 0

Summary
Brief summary
Metoclopramide is a frequently used drug in emergency departments. It can cause unpleasant side effects called akathisia. We are trying to find out if giving the metoclopramide slowly makes getting akathisia less likely.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27409 0
Address 27409 0
Country 27409 0
Phone 27409 0
Fax 27409 0
Email 27409 0
Contact person for public queries
Name 10664 0
Dr Diana Egerton-Warburton
Address 10664 0
Monash Medical Centre
Locked Bag 29
Clayton South VIC 6169
Country 10664 0
Australia
Phone 10664 0
0395942707
Fax 10664 0
0395946564
Email 10664 0
[email protected]
Contact person for scientific queries
Name 1592 0
Dr Kirsty Povey
Address 1592 0
Monash Medical Centre
Locked Bag 29
Clayton South VIC 6169
Country 1592 0
Australia
Phone 1592 0
0395942707
Fax 1592 0
0395946564
Email 1592 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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