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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Device: Skin conductance monitor for measuring skin conductance


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: skin conductance<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin conductance measurements | The skin conductance monitor will be attached to the patient in the Post-Anesthesia Care Unit (PACU) for 1 hour and the skin condutance values will be analyzed off-line. Corresponding pain scores on a scale of 0-10 using the FLACC (Face, Legs, Activity, Cry and Consolibility) 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-operaive pain scores | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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genetic polymorphisms