Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000019404
Ethics application status
Approved
Date submitted
8/01/2007
Date registered
10/01/2007
Date last updated
1/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of awake suggestion on propofol induced pain during intravenous induction of anaesthesia: a randomised controlled trial
Scientific title
The effects of awake suggestion on propofol induced pain during intravenous induction of anaesthesia: a randomised controlled trial
Secondary ID [1] 295713 0
nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
PIPPI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain on injection in patients undergo anaesthesia 1520 0
Condition category
Condition code
Anaesthesiology 1618 1618 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be given the suggestion that "I am going to give you the anaesthetic now" (Intervention). This is said just prior to and during intravenous induction of anaesthesia with Propofol.

Intervention code [1] 1539 0
Prevention
Comparator / control treatment
Patients will be given the suggestion that "I am going to give you the anaesthetic now, it may sting as it goes up the arm". This is said just prior to and during intravenous induction of anaesthesia with Propofol."
Control group
Active

Outcomes
Primary outcome [1] 2231 0
Pain on injection as measured by observing the patient's response from the commencement of propofol administration to loss of consciousness by an independant observer unaware of the intervention. 0 response - no grimace or withdrawal; 1= minimal movement or slight grimace; 2= clear grimace and / or moderate movement; 3 = vocalising pain
Timepoint [1] 2231 0
At the commencement of propofol administration to loss of consciousness
Secondary outcome [1] 3893 0
Recall of pain on injection of Propofol as measured by VNRS Pain scores postoperatively
Timepoint [1] 3893 0
Postoperatively in recovery or on the ward

Eligibility
Key inclusion criteria
Adults presenting for intravenous induction of anaesthesia with propofol.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Propofol allergy; soya bean /egg allergy; severe intellectual handicap; deafness; needing an english interpreter.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consecutively numbered opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects, Observer, Data analysis will be blinded
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/01/2007
Actual
1/07/2018
Date of last participant enrolment
Anticipated
1/07/2021
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
21
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 1765 0
Hospital
Name [1] 1765 0
Women's and Children's Hospital
Country [1] 1765 0
Australia
Primary sponsor type
Individual
Name
Dr A.M Cyna
Address
Women's and Children's Health Network (WCHN), 72 king William Rd SA SA5006
Country
Australia
Secondary sponsor category [1] 1569 0
None
Name [1] 1569 0
none
Address [1] 1569 0
none
Country [1] 1569 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3296 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 3296 0
Ethics committee country [1] 3296 0
Australia
Date submitted for ethics approval [1] 3296 0
01/05/2015
Approval date [1] 3296 0
Ethics approval number [1] 3296 0
Ethics committee name [2] 301114 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [2] 301114 0
Women's and Children's Hospital, 72 King William Rd, North Adelaide SA 5006
Ethics committee country [2] 301114 0
Australia
Date submitted for ethics approval [2] 301114 0
06/04/2015
Approval date [2] 301114 0
01/07/2015
Ethics approval number [2] 301114 0
HREC/15/WCHN/22

Summary
Brief summary
This study plans to investigate whether statements made during intravenous induction of anaesthesia with propofol affect the perception of pain on injection.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27473 0
Dr Allan cyna
Address 27473 0
Dept. Women's Anaesthesia, Women's and Children's Hospital, 72 King William Rd, SA 5006
Country 27473 0
Australia
Phone 27473 0
+61433707067
Fax 27473 0
Email 27473 0
allan.cyna@sa.gov.au
Contact person for public queries
Name 10728 0
A/Prof Dr A.M. Cyna
Address 10728 0
Department of Women's Anaesthesia
Women's and Children's Hospital
72 King William Road
Adelaide SA 5006
Country 10728 0
Australia
Phone 10728 0
+61 8 81617000
Fax 10728 0
Email 10728 0
allan.cyna@sa.gov.au
Contact person for scientific queries
Name 1656 0
Dr Dr A.M. Cyna
Address 1656 0
Department of Women's Anaesthesia
Women's and Children's Hospital
72 King William Road
Adelaide SA 5006
Country 1656 0
Australia
Phone 1656 0
+61 8 81617000
Fax 1656 0
Email 1656 0
allan.cyna@sa.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.