Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000548437
Ethics application status
Approved
Date submitted
28/08/2007
Date registered
24/10/2007
Date last updated
6/05/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient controlled sedation with propofol for emergency department procedures
Scientific title
Total propofol dose in physician versus patient controlled sedation for emergency department procedures
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Procedural sedation in the emergency department 2501 0
Condition category
Condition code
Anaesthesiology 2401 2401 0 0
Pain management
Anaesthesiology 2598 2598 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A prospective, unblinded, randomised controlled trial will be conducted at a metropolitan tertiary-referral teaching hospital ED with an annual census of 70,000. The use of propofol for procedural sedation by emergency physicians or advanced trainees is an established practice in our ED. After administration of analgesia and confirmation of the diagnosis, eligible patients will be invited to participate in the study. Consented participants will then be randomised to the emergency physician-administered (EPA) propofol sedation group or the patient-controlled propofol sedation (PCS) group. The EPA group will receive propofol sedation at the discretion of the treating physician. The PCS group will undergo sedation using a patient-controlled infusion pump containing propofol. An initial bolus of 0.5-0.75mg/kg will be delivered, followed by self-administered increments of 20 mg with a lockout period of 1 minute.
Intervention code [1] 2022 0
Treatment: Drugs
Comparator / control treatment
Physician administered propofol as per current practice
Initial bolus dose: 1 mg/kg IV
Subsequent bolus doses: 1 mg/kg IV titrated to response
Total maximum dose: mg/kg IV
Control group
Dose comparison

Outcomes
Primary outcome [1] 3508 0
Total propofol dose
Timepoint [1] 3508 0
At end of procedural sedation
Secondary outcome [1] 5857 0
Length of sedation, depth of sedation, patient satisfaction, ease of procedure for the clinician and adverse event rates
Timepoint [1] 5857 0
At end of procedural sedation

Eligibility
Key inclusion criteria
Patient requiring a procedural sedation as part of their treatment in the emergency department
Minimum age
16 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inadequate English language comprehension,
Physical inability to use the handset of a patient-controlled infusion pump,
Known allergy or hypersensitivity to propofol,
Anticipated airway difficulty,
Pregnancy

Pregnancy.

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)
Eligible patients will be identified by their treating doctor. Treatment assignments will be randomised into blocks of four patients with the aid of a random number table. Study instructions, data sheets and treatment arm will be placed in serially-numbered, opaque envelopes for use with consecutive enrolments. This envelop is to be opened only after written consent has been provided by the participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatment assignments will be randomised into blocks of four patients with the aid of a random number table by an associate not involved in patient enrolment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 420 0
4006

Funding & Sponsors
Funding source category [1] 2747 0
Self funded/Unfunded
Name [1] 2747 0
Country [1] 2747 0
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Butterfield St
Herston 4006
Country
Australia
Secondary sponsor category [1] 2482 0
None
Name [1] 2482 0
Address [1] 2482 0
Country [1] 2482 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4666 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 4666 0
Butterfield St
Herston 4006
Ethics committee country [1] 4666 0
Australia
Date submitted for ethics approval [1] 4666 0
11/10/2006
Approval date [1] 4666 0
16/02/2007
Ethics approval number [1] 4666 0
2006/179

Summary
Brief summary
Procedural sedation is frequently used in Emergency Departments (ED) for orthopaedic reductions, cardioversions and other painful but brief procedures. Various pharmacologic agents have been used, including nitrous oxide, ketamine, propofol and combinations of benzodiazepine and opioid. Propofol, a potent, short-acting sedative agent, has gained widespread popularity and has been shown to be safe for procedural sedation in the ED. The advantages of propofol include rapid onset, short duration of action, antiemetic effect and high degree of patient satisfaction. Potential disadvantages include deep sedation, apnoea and hypotension.

Patient controlled sedation (PCS) has been investigated for more than 20 years, primarily for minor procedures in the operating theatre, such as colonoscopy and dental extractions. The potential advantage of the PCS technique is that the patient is able to match their sedation requirement with the noxious stimuli and titrate themselves to an appropriate level of sedation without the risk of over-sedation. A second potential advantage of PCS is the psychological benefit it confers on its user with a sense of control over a stressful and painful procedure. Little data has been published on the use of PCS in the ED setting. The objective of this study is to investigate the efficacy of using propofol in a standard patient-controlled infusion pump for procedural sedation in the ED.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28012 0
Address 28012 0
Country 28012 0
Phone 28012 0
Fax 28012 0
Email 28012 0
Contact person for public queries
Name 11169 0
Anthony Bell
Address 11169 0
Royal Brisbane and Women's Hospital
Butterfield St
Herston 4006
Country 11169 0
Australia
Phone 11169 0
0736367901
Fax 11169 0
0736361643
Email 11169 0
[email protected]
Contact person for scientific queries
Name 2097 0
Kevin Chu
Address 2097 0
Royal Brisbane and Women's Hospital
Butterfield St
Herston 4006
Country 2097 0
Australia
Phone 2097 0
0736367901
Fax 2097 0
0736361643
Email 2097 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
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