Post-surgical Pain Assessment in Children: Roles of Skin Conductance and Genomics

NCT02534168 | Terminated

• 1 other identifier: 00002488
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

Pain assessment in infants and toddlers is quite challenging since children in these populations are nonverbal or preverbal and cannot describe the presence and severity of pain that they perceive. Over the last decade, advances in the field have included the development of behavioral scoring systems for the assessment of acute pain . However, although they have been validated, these commonly used methods of pain assessment are largely subjective and rely on a highly trained observer. An objective continuous measure of pain would be an important addition to standard behavioral pain scores which require nurses to monitor the child's behavioral responses.

Conditions

Pain

Keywords

genetic polymorphisms

Outcome Measures

Primary Outcomes (1)

• skin conductance measurements

  The skin conductance monitor will be attached to the patient in the Post-Anesthesia Care Unit (PACU) for 1 hour and the skin conductance values will be analyzed off-line. Corresponding pain scores on a scale of 0-10 using the FLACC (Face, Legs, Activity, Cry and Consolability) scale will be noted every 5 minutes for a period of 1 hour. The skin conductance values will be measured in microsiemens, also the frequency of the skin conductance responses per second will be measured. The ability of skin conductance monitor to predict post-operative pain scores, sensitivity and specificity will be measured.

  2 years

Secondary Outcomes (1)

• Effect of single nucleotide polymorphisms in the mu-opioid receptor A118G on post-operative pain scores

  2 years

Study Arms (1)

skin conductance

The skin conductance monitor will be applied to all study patient. There is no second arm to the study

Device: Skin conductance monitor for measuring skin conductance

Interventions

Skin conductance monitor for measuring skin conductance DEVICE

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, support@med-storm.com) includes cables, skin electrodes, a measurement unit and a monitor.

skin conductance

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The study population will be children less than 5 years of age presenting for palatoplasty or tonsillectomy/adenoidectomy. These will be otherwise healthy children, ASA physical status 1 - 3.

You may qualify if:

• Children \<5 years of age
• Presenting for palatal repair (palatoplasty) or tonsillectomy/adenoidectomy
• American Society of Anesthesiologists (ASA) physical status of 1 - 3

You may not qualify if:

• Children \> 5 years of age
• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (9)

• 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.

  PMID: 18052991 BACKGROUND

• 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.

  PMID: 19672172 BACKGROUND

• 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.

  PMID: 17845649 BACKGROUND

• 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.

  PMID: 10952711 BACKGROUND

• 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.

  PMID: 9220806 BACKGROUND

• 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.

  PMID: 18997532 BACKGROUND

• 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.

  PMID: 16879459 BACKGROUND

• 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.

  PMID: 23046994 BACKGROUND

• 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.

  PMID: 21127283 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood sample will be drawn for genomic analysis in the lab

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Priti G Dalal, MD, FRCA

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: August 27, 2015
• Study Start: November 16, 2015
• Primary Completion: August 12, 2020
• Study Completion: August 12, 2020
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

US (1)