Skin Conductance Monitoring for Pain in Children

PD
LS
Overseen ByLinda Sanger
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Milton S. Hershey Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on finding a better way to measure pain in young children who cannot speak. It uses a Skin Conductance Monitor, which measures skin conductance (indicating sweat levels) to provide an objective, continuous assessment of pain. The study aims to improve the understanding and management of pain during procedures like palatal repair or tonsil/adenoid removal. Children under 5 years old, who are not on chronic pain treatment and have not used painkillers before surgery, may qualify for this trial. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could transform pediatric pain management.

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.

What prior data suggests that this skin conductance monitor is safe for children?

Research has shown that skin conductance monitoring for assessing pain levels in children and infants is safe. This method measures pain continuously and objectively without harming the patient. Studies have not reported any negative effects, indicating it is well-tolerated and safe for young children.12345

Why are researchers excited about this trial?

Researchers are excited about skin conductance monitoring for pain in children because it offers a non-invasive way to objectively measure pain. Unlike traditional methods, which rely on subjective assessments like asking a child to rate their pain, this approach uses a device that detects changes in skin conductance linked to pain responses. This technology could provide more accurate and immediate feedback, potentially leading to better pain management for young patients.

What evidence suggests that skin conductance monitoring is effective for pain assessment in children?

Research shows that skin conductance monitoring safely measures pain in children and infants. Studies have found that this method accurately predicts pain levels after surgery, reliably indicating when a child is in pain. As an objective tool, skin conductance monitoring does not rely solely on observing signs of pain, making it a valuable addition to traditional methods. Recent studies highlight its usefulness in neonatal intensive care units, where accurate pain measurement is crucial. Overall, skin conductance monitoring offers a promising way to assess pain in children who cannot speak. In this trial, all participants will undergo skin conductance monitoring to evaluate its effectiveness in assessing pain.23678

Who Is on the Research Team?

PG

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.
See 4 more

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?
1Treatment groups
Experimental Treatment
Group I: skin conductanceExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials
515
Recruited
2,873,000+

Citations

Post-surgical Pain Assessment in Children: Roles of Skin ...The ability of skin conductance monitor to predict post-operative pain scores, sensitivity and specificity will be measured. 2 years. Secondary Outcome Measures ...
Skin Conductance Monitoring for Pain in ChildrenResearch indicates that skin conductance monitoring has been used safely in children and infants to assess pain, with no specific safety concerns reported in ...
Skin conductance algesimetry for monitoring postoperative...The CHIPPS score has been validated for postoperative pain assessment in children from 3 months to 5 years of age. This score comprises 5 items (each ranging ...
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/19672172/
a tool for the assessment of postoperative pain in children?Background: Monitoring changes in electrical skin conductance has been described as a potentially useful tool for the detection of acute pain in adults.
Analysis of acute pain scores and skin conductance ...Recent literature suggests the use of skin conductance (SC) as an objective physiologic index for assessment of pain in the neonatal intensive care unit and the ...
Skin conductance measurement as a selective and ...Skin conductance measurements provide an objective and continuous method for pain assessment. This gives the possibility to define which parts of an ...
Normalized skin conductance level could differentiate ...Skin conductance, especially nSCL, was found to be able to distinguish between physical pain stimuli and other sympathetic stimuli. Painful ...
are near-infrared spectroscopy, skin conductance, salivary ...Foot skin conductance was monitored with the Med-Storm Pain Monitor. Three electrodes were placed on the sole of one foot. According to previous findings ...
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