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

July 9, 2025 updated by: Priti G. Dalal, Milton S. Hershey Medical Center
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

162

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 years (Child)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
skin conductance measurements
Time Frame: 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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of single nucleotide polymorphisms in the mu-opioid receptor A118G on post-operative pain scores
Time Frame: 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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Priti G Dalal, MD, FRCA, Milton S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2015

Primary Completion (Actual)

August 12, 2020

Study Completion (Actual)

August 12, 2020

Study Registration Dates

First Submitted

August 21, 2015

First Submitted That Met QC Criteria

August 24, 2015

First Posted (Estimated)

August 27, 2015

Study Record Updates

Last Update Posted (Actual)

July 14, 2025

Last Update Submitted That Met QC Criteria

July 9, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00002488

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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