NCT02534168

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 162 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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.

Detailed description

After standard general anesthetic mask induction, 0.5 ml of blood will be drawn for genetic analysis when the intravenous catheter is sited. A member of the research team will manually transport an appropriately-labeled blood collection tube to the Department of Anesthesiology Perioperative Genomics Laboratory for storage and further preparation for genetic analysis. The samples will be stored until the investigators have enough to process. The results will be stored in a secure database. The surgical procedure, anesthesia technique, intraoperative analgesia treatment and initial postoperative analgesia treatment will be standardized.Upon arrival in the Post-Anesthesia Care Unit (PACU), the child will be connected to standard monitors as per standard of care. Pain scores will be recorded on a scale of 0-10 (FLACC, Face, legs,activity, cry, consolability scale) scale. A member of the research team will apply the skin conductance (SC) monitor on the child's hand or foot.This will be used to measure SC values that will be saved on a laptop computer and the SC data will be analyzed off-line.

Conditions

• Pain

Interventions

Type	Name	Description
DEVICE	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, [e-mail]) includes cables, skin electrodes, a measurement unit and a monitor.

Timeline

• Start date: 2015-11-16
• Primary completion: 2020-08-12
• Completion: 2020-08-12
• First posted: 2015-08-27
• Last updated: 2025-07-14

Locations

1 site across 1 country: United States