ANZCTR - Registration

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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

Condition category

Condition code

Anaesthesiology

Pain management

Anaesthesiology

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]

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]

Total propofol dose

Timepoint [1]

At end of procedural sedation

Secondary outcome [1]

Length of sedation, depth of sedation, patient satisfaction, ease of procedure for the clinician and adverse event rates

Timepoint [1]

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?

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]

4006

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Hospital

Name

Royal Brisbane and Women's Hospital

Address

Butterfield St
Herston 4006

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Brisbane and Women's Hospital

Ethics committee address [1]

Butterfield St 
Herston 4006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/10/2006

Approval date [1]

16/02/2007

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Anthony Bell

Address

Royal Brisbane and Women's Hospital
Butterfield St
Herston 4006

Country

Australia

Phone

0736367901

Fax

0736361643

anthony_bell@health.qld.gov.au

Contact person for scientific queries

Name

Kevin Chu

Address

Royal Brisbane and Women's Hospital
Butterfield St
Herston 4006

Country

Australia

Phone

0736367901

Fax

0736361643

kevin_chu@health.qld.gov.au

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.

Trial Review

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