Droperidol OR Midazolam (DORM) for sedation in patients with psychostimulant induced agitation

A randomised controlled trial of intramuscular droperidol versus intramuscular midazolam for rapid sedation of aggressive and agitated psychostimulant-associated delirium

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000527460

Acronym

DORM

Enrollment

Registered

2007-10-12

Start date

2008-08-27

Completion date

2009-07-25

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

Aggressive behaviour related to psychostimulant abuse, poisoning and/or withdrawal, such as amphetamines, is an increasing problem in emergency departments. It can lead to patient harm, injury to staff and damage to hospital property if the situation is not rapidly controlled. Intravenous sedation can be difficult, particularly in smaller urban and regional hospitals because it requires sufficient staff numbers to restrain the patient to obtain intravenous access and can lead to needle-stick injuries. Intramuscular sedation with benzodiazepines, mainly midazolam, is unpredictable and can lead to over-sedating the patient or not sedating them enough, and may be associated with problems in this group due to benzodiazepine tolerance. Droperidol is a highly sedative antipsychotic medication that is rarely associated with complications. This study aims to compare the effectiveness of intramuscular droperidol and intramuscular benzodiazepines for sedation of aggressive patients with psychostimulant associated agitation in a randomised controlled trial. The study is designed to assess both the speed of onset and duration of sedation.

Interventions

Intramuscular droperidol, single 10mg dose

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Emergency department patients with suspected or confirmed severe agitated delirium/psychosis or aggression due to psychostimulant toxicity; AND require intervention by hospital security staff or physical restraint

Exclusion criteria

1. Patients with acute psychosis clearly due to other causes; 2. Patient who are willing to take oral or intravenous medication for sedation without physical restraint; 3. Patients under the age of 18 years of age;

Outcome results