Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000583246
Ethics application status
Approved
Date submitted
10/07/2009
Date registered
14/07/2009
Date last updated
14/07/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Predictive value of skin conductance monitoring and assessment of heart rate variability for postoperative pain in paediatric patients
Scientific title
Paediatric patients: Observation of skin conductance and heart rate variability and their correlation with actute postoperative pain
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute postoperative pain 237212 0
Condition category
Condition code
Anaesthesiology 237530 237530 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The trial will commence with admission of the patients to the recovery room and will end with their discharge from this area. During their stay in recovery patients' pain will be rated 5 minutely on a numerical rating scale, the faeces legs arms cry consolability (FLACC) scale and the revised faeces scale (by recovery room nurse). At the same time, the skin conductance parameter "number of skin conductance fluctuations per second" (NFSC) (MedStorm Innovations, Oslo, Norway) will be measured via 3 electrodes applied to the surface of the hand. Additionaly, data downloaded from the standard recovery room monitor (AS5, GE Healthcare, Helsinki, Finland) will be used to calculate heart rate variability parameters (MemCalc, Tarawa Suwa Trust, Tokyo, Japan). Data of blood pressure, heart rate and respiration rate will also be downloaded (standard serial port connection) onto a laptop PC at the same time points.
Aim of this part of the trial is the investigation of the relationship of above parameters with postoperative pain defined on above mentioned standard scales.
Additionally, we aim to prospectively investigate the value of a cut-off point for the skin conductance parameter NFSC that has been defined in an earlier study using the same methodology in 2007-2008 (ACTRN12607000474459).
This will be done by using the defined cut-off (0.13) as a descriptor for pain and comparing the outcome with the "true" rating of pain done by the (blinded) recovery room nurse (see above).
Intervention code [1] 236911 0
Not applicable
Comparator / control treatment
As there is no gold standard for pain assessment, pain will be measured as control on standard clinical scores used every day in recovery units around the world: numeric rating scale (NRS), faeces legs, arms, cry, consolability (FLACC) scale and revised faeces scale.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238343 0
Correlation between parameters of skin conductance and heart rate variability and acute postoperative pain.
The trial will commence with admission of the patients to the recovery room and will end with their discharge from this area. During their stay in recovery patients' pain will be rated 5 minutely on a numerical rating scale, the FLACC scale and the revised faeces scale (by recovery room nurse). At the same time, the skin conductance parameter NFSC (MSI, Oslo, Norway) will be measured via 3 electrodes applied to the surface of the hand. Additionaly, data downloaded from the standard recovery room monitor (AS5, GE Healthcare, Helsinki, Finland) will be used to calculate heart rate variability parameters (MemCalc, Tarawa Suwa Trust, Tokyo, Japan). Data of blood pressure, heart rate and respiration rate will also be downloaded (standard serial port connection) onto a laptop PC at the same time points.
Aim of this part of the trial is the investigation of the relationship of above parameters with postoperative pain defined on above mentioned standard scales.
Timepoint [1] 238343 0
Various time points of pain assessment during the stay in the recovery room ( 5 minutely assessment of pain, see above).
Secondary outcome [1] 244751 0
Additionally, we aim to prospectively investigate the value of a cut-off point for the skin conductance parameter NFSC that has been defined in an earlier study using the same methodology in 2007-2008 (ACTRN12607000474459).
This will be done by using the defined cut-off (0.13) as a descriptor for pain and comparing the outcome with the "true" rating of pain done by the (blinded) recovery room nurse (see above).
Timepoint [1] 244751 0
Various time points during the stay in the recovery room (5 minutley assessments of pain, see above).

Eligibility
Key inclusion criteria
peadiatric patients 1-16 years, non-emergency surgery
Minimum age
1 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
missing consent, pacemaker, inability to communicate (only 8-16 years), syndromes, medication with atropine/glycopyrrolate/clonidine/ketamine/ catecholamines

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237308 0
Self funded/Unfunded
Name [1] 237308 0
Prof. Thomas Ledowski
Country [1] 237308 0
Australia
Primary sponsor type
Individual
Name
Prof. Thomas Ledowski
Address
Dept. of Anaesthesia
Royal Perth Hospital
Perth WA 6000
Country
Australia
Secondary sponsor category [1] 236793 0
None
Name [1] 236793 0
Address [1] 236793 0
Country [1] 236793 0
Other collaborator category [1] 756 0
Individual
Name [1] 756 0
Italo Zamudio
Address [1] 756 0
Dept. of Anaesthesia
Princess Margaret Hospital for Children
Roberts Rd, Subiaco 6008, WA
Country [1] 756 0
Australia
Other collaborator category [2] 761 0
Individual
Name [2] 761 0
Neil Chambers
Address [2] 761 0
Dept. of Anaesthesia
Princess Margaret Hospital for Children
Roberts Rd, Subiaco 6008, WA
Country [2] 761 0
Australia
Other collaborator category [3] 762 0
Individual
Name [3] 762 0
Elaine Pascoe
Address [3] 762 0
Dept. of Anaesthesia
Princess Margaret Hospital for Children
Roberts Rd, Subiaco 6008, WA
Country [3] 762 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239403 0
Princess Margaret Hospital for Children
Ethics committee address [1] 239403 0
Ethics committee of the Princess Margaret Hospital for Children
Roberts Rd.
Subiaco 6008
Western Australia
Ethics committee country [1] 239403 0
Date submitted for ethics approval [1] 239403 0
05/05/2009
Approval date [1] 239403 0
07/07/2009
Ethics approval number [1] 239403 0

Summary
Brief summary
Pain treatment is vital part of postoperative care as a delayed or insufficient treatment of pain can significantly impair a patients outcome. Prerequisite of successfull treatment is the assessment of pain. This can be difficult in younger children who lack the ability to communicate their pain. Aim of this observational trial is to define the relationship between physiological parameters such as blood pressure, heart rate, skin conductance parameters and heart rate variability and acute postoperative pain. At the same time, we aim to prospectively test cut-off values for the skin conductance parameter "number of skin conductance fluctuations per second" (NFSC) obtained in an earlier study to distinguish between no/mild and moderate/severe pain. 150 peadiatric patients aged 1-16 after elective surgery will be included and the relationship between above mentioned parameters and acute postoperative pain (measured on standard pain scales during the patients stay in the recovery room) will be examined.
Trial website
n/a
Trial related presentations / publications
n/a
Public notes

Contacts
Principal investigator
Name 29879 0
Address 29879 0
Country 29879 0
Phone 29879 0
Fax 29879 0
Email 29879 0
Contact person for public queries
Name 13126 0
Prof. Thomas Ledowski
Address 13126 0
Dept. of Anaesthesia
Royal Perth Hospital
Wellington Street Campus
Perth WA 6000
Country 13126 0
Australia
Phone 13126 0
0061 8 9224 1038
Fax 13126 0
Email 13126 0
[email protected]
Contact person for scientific queries
Name 4054 0
Prof. Thomas Ledowski
Address 4054 0
Dept. of Anaesthesia
Royal Perth Hospital
Wellington Street Campus
Perth WA 6000
Country 4054 0
Australia
Phone 4054 0
0061 8 9224 1038
Fax 4054 0
Email 4054 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

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