PainNCT02534168
Post-surgical Pain Assessment in Children: Roles of Skin Conductance and Genomics
An observational study of Pain, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Pain
- What is being tested?
- Skin conductance monitor for measuring skin conductance
- Type of treatment
- Medical device
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2015to 12 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Children <5 years of age
- Presenting for palatal repair (palatoplasty) or tonsillectomy/adenoidectomy
- American Society of Anesthesiologists (ASA) physical status of 1 - 3
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pain
- Being tested
- Skin conductance monitor for measuring skin conductance
- Keywords
- genetic polymorphisms
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin conductance monitor for measuring skin conductanceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| skin conductance | The skin conductance monitor will be applied to all study patient. There is no second arm to the study Receives: Device: Skin conductance monitor for measuring skin conductance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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.
Measured: 2 years
Secondary outcomes (1)
Effect of single nucleotide polymorphisms in the mu-opioid receptor A118G on post-operative 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study start16 Nov 2015
- Primary completion12 Aug 2020
- Study completion12 Aug 2020
Why it stopped: inability to obtain equipment and lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Priti G. Dalal, Milton S. Hershey Medical Center
- Investigators
- Priti G Dalal, MD, FRCA, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534168
- Sponsor's protocol ID
- 00002488
- Status last verified
- Jul 2025
- First submitted
- 21 Aug 2015
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Eriksson M, Storm H, Fremming A, Schollin J. Skin conductance compared to a combined behavioural and physiological pain measure in newborn infants. Acta Paediatr. 2008 Jan;97(1):27-30. doi: 10.1111/j.1651-2227.2007.00586.x. Epub 2007 Dec 3.
PubMed 18052991Hullett B, Chambers N, Preuss J, Zamudio I, Lange J, Pascoe E, Ledowski T. Monitoring electrical skin conductance: a tool for the assessment of postoperative pain in children? Anesthesiology. 2009 Sep;111(3):513-7. doi: 10.1097/ALN.0b013e3181b27c18.
PubMed 19672172Ledowski T, Bromilow J, Wu J, Paech MJ, Storm H, Schug SA. The assessment of postoperative pain by monitoring skin conductance: results of a prospective study. Anaesthesia. 2007 Oct;62(10):989-93. doi: 10.1111/j.1365-2044.2007.05191.x.
PubMed 17845649Storm H. Skin conductance and the stress response from heel stick in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2000 Sep;83(2):F143-7. doi: 10.1136/fn.83.2.f143.
PubMed 10952711Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
PubMed 9220806Storm H. Changes in skin conductance as a tool to monitor nociceptive stimulation and pain. Curr Opin Anaesthesiol. 2008 Dec;21(6):796-804. doi: 10.1097/ACO.0b013e3283183fe4.
PubMed 18997532Chou WY, Yang LC, Lu HF, Ko JY, Wang CH, Lin SH, Lee TH, Concejero A, Hsu CJ. Association of mu-opioid receptor gene polymorphism (A118G) with variations in morphine consumption for analgesia after total knee arthroplasty. Acta Anaesthesiol Scand. 2006 Aug;50(7):787-92. doi: 10.1111/j.1399-6576.2006.01058.x.
PubMed 16879459Dalal PG, Doheny KK, Klick L, Britcher S, Rebstock S, Bezinover D, Palmer C, Berlin C, Postula M, Kong L, Janicki PK. Analysis of acute pain scores and skin conductance measurements in infants. Early Hum Dev. 2013 Mar;89(3):153-8. doi: 10.1016/j.earlhumdev.2012.09.008. Epub 2012 Oct 6.
PubMed 23046994Kolesnikov Y, Gabovits B, Levin A, Voiko E, Veske A. Combined catechol-O-methyltransferase and mu-opioid receptor gene polymorphisms affect morphine postoperative analgesia and central side effects. Anesth Analg. 2011 Feb;112(2):448-53. doi: 10.1213/ANE.0b013e318202cc8d. Epub 2010 Dec 2.
PubMed 21127283
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-surgical Pain Assessment in Children: Roles of Skin Conductance and Genomics
- ClinicalTrials.gov ID
- NCT02534168
- Acronym / sponsor ID
- 00002488
- Conditions
- Pain
- Keywords
- genetic polymorphisms
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: inability to obtain equipment and lack of funding.
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 16 Nov 2015 (actual)
- Primary completion
- 12 Aug 2020 (actual)
- Study completion
- 12 Aug 2020 (actual)
- First posted
- 27 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| skin conductance | – | Device: Skin conductance monitor for measuring skin conductanceThe skin conductance monitor will be applied to all study patient. There is no second arm to the study |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Children <5 years of age
- Presenting for palatal repair (palatoplasty) or tonsillectomy/adenoidectomy
- American Society of Anesthesiologists (ASA) physical status of 1 - 3
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin conductance monitor for measuring skin conductanceThe 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. | Device | skin conductance |
Primary outcome
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.
1 secondary outcome
Effect of single nucleotide polymorphisms in the mu-opioid receptor A118G on post-operative pain scores
Time frame: 2 years
Results and safety
The study was stopped early (reason given: inability to obtain equipment and lack of funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Results publication: PubMed 18052991Eriksson M, Storm H, Fremming A, Schollin J. Skin conductance compared to a combined behavioural and physiological pain measure in newborn infants. Acta Paediatr. 2008 Jan;97(1):27-30. doi: 10.1111/j.1651-2227.2007.00586.x. Epub 2007 Dec 3.
- Results publication: PubMed 19672172Hullett B, Chambers N, Preuss J, Zamudio I, Lange J, Pascoe E, Ledowski T. Monitoring electrical skin conductance: a tool for the assessment of postoperative pain in children? Anesthesiology. 2009 Sep;111(3):513-7. doi: 10.1097/ALN.0b013e3181b27c18.
- Results publication: PubMed 17845649Ledowski T, Bromilow J, Wu J, Paech MJ, Storm H, Schug SA. The assessment of postoperative pain by monitoring skin conductance: results of a prospective study. Anaesthesia. 2007 Oct;62(10):989-93. doi: 10.1111/j.1365-2044.2007.05191.x.
- Results publication: PubMed 10952711Storm H. Skin conductance and the stress response from heel stick in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2000 Sep;83(2):F143-7. doi: 10.1136/fn.83.2.f143.
- Results publication: PubMed 9220806Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
- Results publication: PubMed 18997532Storm H. Changes in skin conductance as a tool to monitor nociceptive stimulation and pain. Curr Opin Anaesthesiol. 2008 Dec;21(6):796-804. doi: 10.1097/ACO.0b013e3283183fe4.
- Results publication: PubMed 16879459Chou WY, Yang LC, Lu HF, Ko JY, Wang CH, Lin SH, Lee TH, Concejero A, Hsu CJ. Association of mu-opioid receptor gene polymorphism (A118G) with variations in morphine consumption for analgesia after total knee arthroplasty. Acta Anaesthesiol Scand. 2006 Aug;50(7):787-92. doi: 10.1111/j.1399-6576.2006.01058.x.
- Results publication: PubMed 23046994Dalal PG, Doheny KK, Klick L, Britcher S, Rebstock S, Bezinover D, Palmer C, Berlin C, Postula M, Kong L, Janicki PK. Analysis of acute pain scores and skin conductance measurements in infants. Early Hum Dev. 2013 Mar;89(3):153-8. doi: 10.1016/j.earlhumdev.2012.09.008. Epub 2012 Oct 6.
- Results publication: PubMed 21127283Kolesnikov Y, Gabovits B, Levin A, Voiko E, Veske A. Combined catechol-O-methyltransferase and mu-opioid receptor gene polymorphisms affect morphine postoperative analgesia and central side effects. Anesth Analg. 2011 Feb;112(2):448-53. doi: 10.1213/ANE.0b013e318202cc8d. Epub 2010 Dec 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Priti G Dalal, MD, FRCA principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: inability to obtain equipment and lack of funding.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skin conductance measurements (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02534168, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.