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Predictive value of skin conductance monitoring and assessment of heart rate variability for postoperative pain in paediatric patients

Paediatric patients: Observation of skin conductance and heart rate variability and their correlation with actute postoperative pain

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12609000583246
Enrollment
150
Registered
2009-07-14
Start date
2009-07-21
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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).

Sponsors

Prof. Thomas Ledowski
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
1 Years to 16 Years
Healthy volunteers
No

Inclusion criteria

peadiatric patients 1-16 years, non-emergency surgery

Exclusion criteria

missing consent, pacemaker, inability to communicate (only 8-16 years), syndromes, medication with atropine/glycopyrrolate/clonidine/ketamine/ catecholamines

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026