A Randomised Controlled Trial of Bolus Versus Fifteen Minute Infusion of Metoclopramide to Determine the Incidence and Severity of Drug Induced Akathisia.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000121460

Enrollment

200

Registered

2007-02-09

Start date

2007-02-12

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients receiving metoclopramide in the ED for any indication.

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.

Outcome results