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Report for Clinical Trial NCT02534168

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT02534168 Pain

1 Interventions

Name: Skin conductance monitor for measuring skin conductance

Description: 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.

Type: Device

skin conductance


Primary Outcomes

Description: 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.

Measure: skin conductance measurements

Time: 2 years

Secondary Outcomes

Description: Association of the mu-opioid receptor gene A118G polymorphisms with inter-individual differences in the pain scores with standardized treatments will be evaluated.

Measure: Effect of single nucleotide polymorphisms in the mu-opioid receptor A118G on post-operaive pain scores

Time: 2 years

Purpose: Diagnostic

Single Group Assignment


There is one SNP

SNPs


1 A118G

The ability of skin conductance monitor to predict post-operative pain scores, sensitivity and specificity will be measured.. Effect of single nucleotide polymorphisms in the mu-opioid receptor A118G on post-operaive pain scores. --- A118G ---

Association of the mu-opioid receptor gene A118G polymorphisms with inter-individual differences in the pain scores with standardized treatments will be evaluated.. 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 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 Pain After standard general anesthetic mask induction, 0.5 ml of blood will be drawn for genetic analysis when the intravenous catheter is sited. --- A118G ---



HPO Nodes