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

Penn State Health

Status: Terminated

Conditions: Pain

Treatments: Device: Skin conductance monitor for measuring skin conductance

Study type: Observational

Funder types: Other

Identifiers

NCT02534168

00002488

Details and patient eligibility

About

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.

Full 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.

Enrollment: 162 patients

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

162 participants in 1 patient group

skin conductance

Description:

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

Treatment:

Device: Skin conductance monitor for measuring skin conductance