Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000474459
Ethics application status
Approved
Date submitted
6/08/2007
Date registered
21/09/2007
Date last updated
21/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Observational trial of correlations between skin conductance and postoperative pain in children
Scientific title
Observational trial of correlations between skin conductance and postoperative pain in children
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pain after an operation while in the recovery room 2221 0
Condition category
Condition code
Other 2312 2312 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Once the patients arrive in the recovery room, skin conductance will be assessed via 3 standard electrocardiogram (ECG) electrodes on the hand. The correlation of these measures with the pain score of the patients at the same time will be assessed. The assessment is limited to the time the patients spend in the recovery room.
Intervention code [1] 2012 0
Not applicable
Comparator / control treatment
not applicable, as observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3209 0
Correlation between postoperative pain in the recovery room with skin conductance variables
Timepoint [1] 3209 0
during the stay in the recovery room
Primary outcome [2] 3293 0
correlation between skin conductance readings and pain (assessed on a pain score) in the recovery room
Timepoint [2] 3293 0
during stay in the recovery room
Secondary outcome [1] 5348 0
Predictability of pain by skin conductance variables obtained at the same time
Timepoint [1] 5348 0
during the stay in the recovery room
Secondary outcome [2] 5480 0
Can skin conductance distinguish states in which pain is not existing/low and moderate/severe in the postoperative recovery room period.
Timepoint [2] 5480 0
during stay in the recovery room

Eligibility
Key inclusion criteria
180 postoperative paediatric patients in the recovery room
Minimum age
1 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neurodevelopmentally delayed
Syndrome or major systemic disease
Patients on drugs that alter autonomic nervous system (ie anticholinergics, antidepressants, ADHD medication)
ASA3-4
No access to patient’s hand(s)
Contact reaction to adhesives

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2478 0
University
Name [1] 2478 0
Anaesthesiology Unit Research Trust
University of Western Australia
Country [1] 2478 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Thomas Ledwoski
Address
Anaesthesiology Unit
School of Medicine and Pharmacology
Level 2, MRF Building, Murray Street
Perth WA 6000
Country
Australia
Secondary sponsor category [1] 2310 0
None
Name [1] 2310 0
Address [1] 2310 0
Country [1] 2310 0
Other collaborator category [1] 42 0
Individual
Name [1] 42 0
Dr. Bruce Hullet
Address [1] 42 0
Princess Margaret Hospital for Children
Perth WA
Country [1] 42 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4382 0
Princess Margaret Hospital for Children
Ethics committee address [1] 4382 0
Perth WA
Ethics committee country [1] 4382 0
Australia
Date submitted for ethics approval [1] 4382 0
Approval date [1] 4382 0
Ethics approval number [1] 4382 0
1376/EP (Ref No. EC07-11)

Summary
Brief summary
Up to today, there is no gold standard available for the assessment of pain in young children after operations. Aim of this trial is to investigate the correlation between pain obtained by behavioural or nurse rated assessment with skin conductance readings obtained at the same time. We hope that by that means we may be able to measure pain objectively and be able to conclude about wether or not a child requires acute pain relief.
We will include 180 patients in 3 age groups (1-3, 4-7 and 8-16 yrs) and observe their pain (nurse assessed, behavioural, self assessed) in the recovery room. At the same time we will obtain skin conductance readings via 3 sticky dots on the hand (a method which itself is absolutely pain-free).
From these readings we will try to find correlations or certain patterns that might allow conclusion about the level of pain by simple skin conductance assessment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27746 0
Address 27746 0
Country 27746 0
Phone 27746 0
Fax 27746 0
Email 27746 0
Contact person for public queries
Name 11121 0
A\Prof. Thomas Ledowski
Address 11121 0
University of Western Australia
Anaesthesiology Unit Royal Perth
Level 2
Hospital MRF Building
GPO Box X2213
Perth SA 6847
Country 11121 0
Australia
Phone 11121 0
0061-(0)8-92240210
Fax 11121 0
Email 11121 0
[email protected]
Contact person for scientific queries
Name 2049 0
A\Prof. Thomas Ledowski
Address 2049 0
University of Western Australia
Anaesthesiology Unit
Royal Perth Hospital
MRF Building Level 2
GPO Box X2213
Perth WA 6847
Country 2049 0
Australia
Phone 2049 0
0061-(0)8-92240210
Fax 2049 0
Email 2049 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
SourceTitleYear of PublicationDOI
Dimensions AIMonitoring Electrical Skin Conductance2009https://doi.org/10.1097/aln.0b013e3181b27c18
N.B. These documents automatically identified may not have been verified by the study sponsor.