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

  • STATUS
    Recruiting
  • End date
    Dec 21, 2022
  • participants needed
    162
  • sponsor
    Milton S. Hershey Medical Center
Updated on 21 March 2022
pain assessment
acute pain

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 painscores which require nurses to monitor the child's behavioral responses.

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.

Details
Condition Pain
Treatment Skin conductance monitor for measuring skin conductance
Clinical Study IdentifierNCT02534168
SponsorMilton S. Hershey Medical Center
Last Modified on21 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Children 0 - 3 years of age inclusive
Presenting for palatal repair (palatoplasty)
American Society of Anesthesiologists (ASA) physical status of 1 or 2

Exclusion Criteria

Children > 3 years of age
On chronic pain treatment
Pre-operative use of analgesics
Allergies to any anesthetics or analgesia products
Known obstructive sleep apnea
Diagnosis of Cystic fibrosis
American Society of Anesthesiologists (ASA) physical status ≥ 3
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