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Trial registered on ANZCTR


Trial ID
ACTRN12614000980639
Ethics application status
Approved
Date submitted
2/09/2014
Date registered
12/09/2014
Date last updated
2/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Intravenous midazolam-droperidol (combination), droperidol (only) or olanzapine (only) for the acutely agitated patient:
A multi-centre, randomised, double-blind, controlled, clinical trial
Scientific title
A randomised clinical trial to compare the efficacy of the intravenous midazolam-droperidol combination, droperidol only and olanzepine only for sedation of the severely agitated patient
Secondary ID [1] 285281 0
nil
Universal Trial Number (UTN)
Trial acronym
SOOTHE Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
severe agitation 292943 0
aggression 292944 0
Condition category
Condition code
Mental Health 293240 293240 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Single intravenous bolus of midazolam (5mg) plus droperidol (5mg). Arm 2: Single intravenous bolus of dropridol (10mg) Arm 3: Single intravenous bolus of olanzapine (10mg)
Intervention code [1] 290171 0
Treatment: Drugs
Comparator / control treatment
The control treatment will be the midazolam-droperidol arm
Control group
Active

Outcomes
Primary outcome [1] 293091 0
Time to sedation as defined by a sedation score of less than or equal to 2 on a 6 point scale (6=highly agitated & violent, 0=asleep)
Timepoint [1] 293091 0
Time to adequate sedation
Secondary outcome [1] 310317 0
Need for re-sedation <60 minutes after achieving sedation (‘rescue’ drug requirement). Resedation will be required if the patient again becomse acutely agitated and is a danger to themsleves of others.
Timepoint [1] 310317 0
within 60 minutes of achieving adequate sedation initially
Secondary outcome [2] 310318 0
Adverse events including airway obstruction, hypoventilation, oxygen desaturation (<90%), hypotension (<90mmHg), movement disorders (eg. dystonic reactions, twitching), seizures, vomiting or aspiration. All events are assessed clinically (observation) or with stadard equipment (sphygmomanometer, saturation probe)
Timepoint [2] 310318 0
within 60 minutes of achieving adequate sedation initially

Eligibility
Key inclusion criteria
Emergency Department patients aged 18-65 years who require IV drug sedation for acute agitation
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. known hypersensitivity or contraindication to the study drugs
2. reversible aetiology for agitation (hypotension, hypoxia, hypoglycaemia)
3. known pregnancy
4. acute alcohol withdrawal (particularly amenable to benzodiazepines alone)

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)
Patients requiring sedation will be determined by Emergency Physicians or Registrars. The next sequential study pack will be assigned to the patient. The study pack will contain the drugs randomly assigned to the patient. All drugs will be blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2952 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 2953 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Funding & Sponsors
Funding source category [1] 289900 0
Charities/Societies/Foundations
Name [1] 289900 0
Australasian College for Emergency Medicine Research Foundation
Address [1] 289900 0
34 Jeffcott Street, West Melbourne, Victoria, 3003
Country [1] 289900 0
Australia
Funding source category [2] 293040 0
Charities/Societies/Foundations
Name [2] 293040 0
Austin Hospital Medical Research Foundation
Address [2] 293040 0
Office for Research
Austin Hospital
Studly Road
Heidelberg
Victoria
3084
Country [2] 293040 0
Australia
Primary sponsor type
Hospital
Name
Austin Hospital
Address
Studley Rd, Heidelberg, Vic 3084
Country
Australia
Secondary sponsor category [1] 288587 0
Hospital
Name [1] 288587 0
Royal Melbourne Hospital
Address [1] 288587 0
Royal Parade, Parkville, Vic 3052
Country [1] 288587 0
Australia
Secondary sponsor category [2] 288588 0
Hospital
Name [2] 288588 0
St Vincent's Hospital
Address [2] 288588 0
Victoria Parade, Fitzroy, Victoria 3065
Country [2] 288588 0
Australia
Secondary sponsor category [3] 288589 0
University
Name [3] 288589 0
Pharmacy College, Monash University
Address [3] 288589 0
Royal Parade, Parkville, Victoria 3052
Country [3] 288589 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291622 0
Melbourne Health
Ethics committee address [1] 291622 0
Royal Melbourne Hospital
Royal Parade
Parkville
Vic
3052
Ethics committee country [1] 291622 0
Australia
Date submitted for ethics approval [1] 291622 0
Approval date [1] 291622 0
14/03/2014
Ethics approval number [1] 291622 0
HREC/13/MH/363

Summary
Brief summary
We believe that the combination of midazolam and droperidol will be superior in efficacy and safety to droperidol alone or olanzapine alone for patients with acute agitation
Trial website
Trial related presentations / publications
none as yet
Public notes

Contacts
Principal investigator
Name 51198 0
Prof David Taylor
Address 51198 0
Emergency Department Austin Hospital Studley Road Heidelberg, Vic 3084
Country 51198 0
Australia
Phone 51198 0
+61 3 9496 4711
Fax 51198 0
Email 51198 0
David.Taylor@austin.org.au
Contact person for public queries
Name 51199 0
Prof David Taylor
Address 51199 0
Emergency Department Austin Hospital Studley Road Heidelberg, Vic 3084
Country 51199 0
Australia
Phone 51199 0
+61 3 9496 4711
Fax 51199 0
Email 51199 0
David.Taylor@austin.org.au
Contact person for scientific queries
Name 51200 0
Prof David Taylor
Address 51200 0
Emergency Department Austin Hospital Studley Road Heidelberg, Vic 3084
Country 51200 0
Australia
Phone 51200 0
+61 3 9496 4711
Fax 51200 0
Email 51200 0
David.Taylor@austin.org.au