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

Not Applicable

Terminated

• Conditions: Pain

• Registration Number: NCT02534168
• Lead Sponsor: Milton S. Hershey Medical Center

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.

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.

Study Timeline

• Study First Submitted: 2015-08-21
• Study First Submitted QC: 2015-08-24
• Study First Posted: 2015-08-27
• Study Start: 2015-11-16
• Primary Completion: 2020-08-12
• Study Completion: 2020-08-12
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-09
• Last Update Posted: 2025-07-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 162

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
skin conductance measurements	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Effect of single nucleotide polymorphisms in the mu-opioid receptor A118G on post-operative pain scores	2 years	Association of the mu-opioid receptor gene A118G polymorphisms with inter-individual differences in the pain scores with standardized treatments will be evaluated.

Trial Locations

Locations (1)

Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States