Droperidol OR Midazolam (DORM) for sedation in patients with psychostimulant induced agitatio
Not Applicable
Completed
- Conditions
- Psychostimulant induced agitation and deliriumInjuries and Accidents - Poisoning
- Registration Number
- ACTRN12607000527460
- Lead Sponsor
- Geoffrey Isbister
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time until all clear by the security staff [ie. patient is safely restrained and sedated] to estimate onset of sedation[Outcome is a measure of time which commences at the time of intramuscular administration of treatment or comparator drugs];Time until the next dose of parenteral medication for sedation to estimate duration of sedation[Outcome is a measure of time]
- Secondary Outcome Measures
Name Time Method Reduction in a 6-point agitation scale (6=highly aroused and violent, 0=asleep)[From baseline to 20 minutes after trial medication];Reduction in the altered mental status scale[From baseline to 20 minutes after trial medication];Injuries to the patient or staff members[During Emergency Department [ED] admission];Requirement for further parenteral sedation[During Emergency Department [ED] admission];Total oral sedation required[During Emergency Department [ED]admission];Further calls for security staff to the patient[During Emergency Department [ED] admission]