Post-surgical Pain Assessment in Children: Roles of Skin Conductance and Genomics
NCT ID: NCT02534168
Last Updated: 2025-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
162 participants
OBSERVATIONAL
2015-11-16
2020-08-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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skin conductance
The skin conductance monitor will be applied to all study patient. There is no second arm to the study
Skin conductance monitor for measuring skin conductance
The Skin conductance monitor for measuring skin conductance on the palm of the hand or sole of the foot in microSiemens (µS); it then calculates the number of skin conductance responses per second and the area under the registration curve.
The device records sympathetic autonomous nervous system through its effect on skin.
The device (Med-Storm Innovation AS, Gimle Terrasse 4, NO-0264 Oslo, Norway, [email protected]) includes cables, skin electrodes, a measurement unit and a monitor.
Interventions
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Skin conductance monitor for measuring skin conductance
The Skin conductance monitor for measuring skin conductance on the palm of the hand or sole of the foot in microSiemens (µS); it then calculates the number of skin conductance responses per second and the area under the registration curve.
The device records sympathetic autonomous nervous system through its effect on skin.
The device (Med-Storm Innovation AS, Gimle Terrasse 4, NO-0264 Oslo, Norway, [email protected]) includes cables, skin electrodes, a measurement unit and a monitor.
Eligibility Criteria
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Inclusion Criteria
* Presenting for palatal repair (palatoplasty) or tonsillectomy/adenoidectomy
* American Society of Anesthesiologists (ASA) physical status of 1 - 3
Exclusion Criteria
* On chronic pain treatment
* Pre-operative use of analgesics
* Allergies to any anesthetics or analgesia products
* Diagnosis of Cystic fibrosis
* American Society of Anesthesiologists (ASA) physical status \> 3
5 Years
ALL
No
Sponsors
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Milton S. Hershey Medical Center
OTHER
Responsible Party
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Priti G. Dalal
Professor
Principal Investigators
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Priti G Dalal, MD, FRCA
Role: PRINCIPAL_INVESTIGATOR
Milton S. Hershey Medical Center
Locations
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Hershey Medical Center
Hershey, Pennsylvania, United States
Countries
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References
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Eriksson M, Storm H, Fremming A, Schollin J. Skin conductance compared to a combined behavioural and physiological pain measure in newborn infants. Acta Paediatr. 2008 Jan;97(1):27-30. doi: 10.1111/j.1651-2227.2007.00586.x. Epub 2007 Dec 3.
Hullett B, Chambers N, Preuss J, Zamudio I, Lange J, Pascoe E, Ledowski T. Monitoring electrical skin conductance: a tool for the assessment of postoperative pain in children? Anesthesiology. 2009 Sep;111(3):513-7. doi: 10.1097/ALN.0b013e3181b27c18.
Ledowski T, Bromilow J, Wu J, Paech MJ, Storm H, Schug SA. The assessment of postoperative pain by monitoring skin conductance: results of a prospective study. Anaesthesia. 2007 Oct;62(10):989-93. doi: 10.1111/j.1365-2044.2007.05191.x.
Storm H. Skin conductance and the stress response from heel stick in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2000 Sep;83(2):F143-7. doi: 10.1136/fn.83.2.f143.
Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
Storm H. Changes in skin conductance as a tool to monitor nociceptive stimulation and pain. Curr Opin Anaesthesiol. 2008 Dec;21(6):796-804. doi: 10.1097/ACO.0b013e3283183fe4.
Chou WY, Yang LC, Lu HF, Ko JY, Wang CH, Lin SH, Lee TH, Concejero A, Hsu CJ. Association of mu-opioid receptor gene polymorphism (A118G) with variations in morphine consumption for analgesia after total knee arthroplasty. Acta Anaesthesiol Scand. 2006 Aug;50(7):787-92. doi: 10.1111/j.1399-6576.2006.01058.x.
Dalal PG, Doheny KK, Klick L, Britcher S, Rebstock S, Bezinover D, Palmer C, Berlin C, Postula M, Kong L, Janicki PK. Analysis of acute pain scores and skin conductance measurements in infants. Early Hum Dev. 2013 Mar;89(3):153-8. doi: 10.1016/j.earlhumdev.2012.09.008. Epub 2012 Oct 6.
Kolesnikov Y, Gabovits B, Levin A, Voiko E, Veske A. Combined catechol-O-methyltransferase and mu-opioid receptor gene polymorphisms affect morphine postoperative analgesia and central side effects. Anesth Analg. 2011 Feb;112(2):448-53. doi: 10.1213/ANE.0b013e318202cc8d. Epub 2010 Dec 2.
Other Identifiers
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00002488
Identifier Type: -
Identifier Source: org_study_id
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