Skin Conductance Monitoring for Pain in Children

Overseen By Linda Sanger

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Must not be taking: Analgesics

Disqualifiers: Chronic pain, Sleep apnea, Cystic fibrosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

162 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes children who are on chronic pain treatment or have used pain relievers before surgery.

Is skin conductance monitoring safe for use in children?

Research indicates that skin conductance monitoring has been used safely in children and infants to assess pain, with no specific safety concerns reported in the studies reviewed. ^{1 2 3 4 5}

How does skin conductance monitoring differ from other treatments for pain in children?

Skin conductance monitoring is unique because it measures electrical changes in the skin to assess pain, offering a more objective method compared to traditional pain assessments that rely on observing behavior, which can be subjective. This method is particularly useful for infants and young children who cannot communicate their pain levels effectively. ^{1 2 4 5 6}

What data supports the effectiveness of the treatment Skin Conductance Monitor for pain in children?

Research suggests that monitoring skin conductance, which measures how the skin's ability to conduct electricity changes, can help detect pain in children, similar to its use in adults. It has been shown to be a sensitive method for identifying and assessing pain severity, especially in situations where communication is difficult, such as with infants or during anesthesia. ^{1 2 3 4 6}

Who Is on the Research Team?

Priti G Dalal, MD, FRCA

Principal Investigator

Milton S. Hershey Medical Center

Are You a Good Fit for This Trial?

This trial is for children aged 0-3 years undergoing palatal repair surgery, who are generally healthy (ASA status 1 or 2). It's not suitable for kids with allergies to anesthetics, sleep apnea, cystic fibrosis, serious health conditions (ASA status ≥3), older than 3 years, on chronic pain treatment or taking painkillers before surgery.

Inclusion Criteria

I am in good or mild systemic disease health according to the ASA.

My child is 0-3 years old and needs surgery to repair the palate.

Exclusion Criteria

I am on a long-term pain management plan.

I use painkillers before surgery.

I have been diagnosed with obstructive sleep apnea.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Procedure and Initial Postoperative Care

Standard general anesthetic mask induction, blood drawn for genetic analysis, and application of skin conductance monitor in the PACU

1 day

1 visit (in-person)

Postoperative Monitoring

Skin conductance values and pain scores recorded every 5 minutes for 1 hour in the PACU

1 hour

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Skin Conductance Monitor

Trial Overview The study aims to test a skin conductance monitor as an objective tool for measuring pain in young children after surgery. This could complement current subjective methods that rely on observing the child's behavior by trained professionals.

How Is the Trial Designed?

Group I: skin conductance Experimental Treatment 1 Intervention

The skin conductance monitor will be applied to all study patient. There is no second arm to the study

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Monitoring electrical skin conductance: a tool for the assessment of postoperative pain in children? [2009]

2. Ireland pubmed.ncbi.nlm.nih.gov

Analysis of acute pain scores and skin conductance measurements in infants. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Assessment of pain in critically ill children. Is cutaneous conductance a reliable tool? [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Skin conductance peaks could result from changes in vital parameters unrelated to pain. [2012]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Postoperative analgesia of newborns using local anesthetic administered through wound irrigation catheter of permanent action]. [2011]

6. United States pubmed.ncbi.nlm.nih.gov

The Validity of Skin Conductance For Assessing Acute Pain in Infants: A Scoping Review. [2020]