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Trial registered on ANZCTR


Registration number
ACTRN12610001056088
Ethics application status
Not yet submitted
Date submitted
1/06/2010
Date registered
1/12/2010
Date last updated
1/12/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Propofol or Ketofol for Emergency Medicine Procedural Sedation- A Randomised Controlled Trial utilising eHealth methodology.
Scientific title
"Ketafol v Propofol in Emergency Department Procedural Sedation to reduce adverse events".
Secondary ID [1] 251912 0
QEMRF-PROJ-2010-028
Queensland Emergency Medicine Research foundation
Universal Trial Number (UTN)
Trial acronym
POKEM Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emergency procedural sedation for painful conditions
eg fracture reductions, joint relocations 257497 0
Condition category
Condition code
Anaesthesiology 257650 257650 0 0
Pain management
Musculoskeletal 257651 257651 0 0
Other muscular and skeletal disorders
Injuries and Accidents 257652 257652 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will compare the use of a commonly used sedative drug – propofol, used alone or in combination with another drug that has sedative and pain relieving properties called ketamine. The idea is that using a combination of the two drugs together will result in lower doses of each being used if they were to be used independent of one another.
1) Initial Dose in ml equates to 0.5mg kg Propofol alone or 0.25mg/kg Ketamine and propofol in combination
2) Subsequent doses are at half those amounts minutely prn
3) The mode of administration is Intravenous injection.
Intervention code [1] 256590 0
Treatment: Drugs
Comparator / control treatment
-Ketamine and Propofol combined v. Propofol alone
0.25mg/kg when combined v. 0.5 mg/kg when propofol alone
-Subsequent doses at half the initial dose minutely
-IV route of administration
- Procedure usually complete within 10 -15 minutes but an average number of doses would be 4-5 including the initial and subsequent doses
- Ketafol is indeed a combination of ketamine and propofol
Control group
Active

Outcomes
Primary outcome [1] 258558 0
Direct non invasive cardiorespiratory monitoring (oxygen saturation, pulse, respiratory rate, end tidal carbon dioxide and apnoea alarm) will be attached to the patient and as such a composite measure of apnoea (failure of return of end tidal carbon dioxide (etCO2) trace for more than 15 seconds), hypoventilation (<8 breaths/minute) or Oxygen saturation (O2 sat) <93%, and the need for an intervention (airway opening manoeuvres or repositioning, airway adjuncts, manual ventilation, or intubation).
Timepoint [1] 258558 0
Baseline then the continously monitored variables will be written down every 3 minutes.
Secondary outcome [1] 264417 0
Hypotension (SBP<90mmHg) using a non invasive blood pressure cuff
Timepoint [1] 264417 0
3 minutely until end of treatment
Secondary outcome [2] 266467 0
Patient experience and satisfaction
Timepoint [2] 266467 0
post procedure

Eligibility
Key inclusion criteria
Need for emergency department procedural sedation
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to provide consent, age <18yrs, pregnancy, soy or egg allergy, Glasgow Coma Scale<15, hypotension, severe systemic disease (American Society Anesthesiologists class IV or greater), uncontrolled hypertension (Blood Pressure>160/90), patients with known Abdominal Aortic Aneurysm or symptomatic Ischaemic Heart Disease.

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)
Following provision of informed consent, patients will be randomised to receive either propofol alone, or ketofol. Each patient will be given a study pack which will contain data collection forms, patient information and consent sheets, as well as an opaque sealed envelope with the allocated treatment printed within.
Due to the instability of ketofol as a mixture, pre-mixing syringes is impractical. Therefore after enrolment a doctor within the Emergency Department, but not involved with the care of the patient will receive the sealed envelope containing a prescription for the study medication, and draw it up with a nurse within the Emergency Department (two practitioners necessary because of schedule 8 laws). 100mg of Study drug/s will be drawn up and diluted up to 20ml of Normal Saline, and then given to the sedationist, who will be blinded to the contents of the syringe. It will contain 5mg/ml of the study drug/s.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation will occur.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
350
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257082 0
Charities/Societies/Foundations
Name [1] 257082 0
Queensland Emergency Medicine Research Foundation
Country [1] 257082 0
Australia
Primary sponsor type
Hospital
Name
QE II Hospital
Address
c/o Emergency Department,
QE II Jubilee Hospital,
cnr Troughton and Kessels Rd, Coopers Plains, QLD 4108
Country
Australia
Secondary sponsor category [1] 256342 0
Hospital
Name [1] 256342 0
Bundaberg Hospital
Address [1] 256342 0
Bourbong Street BUNDABERG QLD 4670
Postal Address: PO BOX 34 BUNDABERG QLD 4670
Country [1] 256342 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260141 0
Princess Alexandra Hospital Ethics Committee
Ethics committee address [1] 260141 0
Ethics committee country [1] 260141 0
Australia
Date submitted for ethics approval [1] 260141 0
14/10/2010
Approval date [1] 260141 0
Ethics approval number [1] 260141 0
HREC/10/QPAH/235

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31244 0
Address 31244 0
Country 31244 0
Phone 31244 0
Fax 31244 0
Email 31244 0
Contact person for public queries
Name 14491 0
Anthony Bell
Address 14491 0
C/O ED
QE II Jubilee Hospital
cnr Kessels Rd and Troughton Rd
Coopers Plains 4108
QLD
Country 14491 0
Australia
Phone 14491 0
+61 7 31374511
Fax 14491 0
Email 14491 0
[email protected]
Contact person for scientific queries
Name 5419 0
Anthony Bell
Address 5419 0
C/O ED
QE II Jubilee Hospital
cnr Kessels Rd and Troughton Rd
Coopers Plains 4108
QLD
Country 5419 0
Australia
Phone 5419 0
+61 7 31374511
Fax 5419 0
Email 5419 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.