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Skin Conductance Monitoring for Pain in Children

N/A
Waitlist Available
Led By Priti G Dalal, MD, FRCA
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
American Society of Anesthesiologists (ASA) physical status of 1 or 2
Children 0 - 3 years of age inclusive presenting for palatal repair (palatoplasty)
Must not have
Known obstructive sleep apnea
American Society of Anesthesiologists (ASA) physical status ≥ 3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at a new way to measure pain in infants and toddlers that is continuous and objective.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves monitoring rather than medication or invasive procedures, there are no direct side effects from the intervention being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am in good or mild systemic disease health according to the ASA.
Select...
My child is 0-3 years old and needs surgery to repair the palate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with obstructive sleep apnea.
Select...
My health is severely impacted by my disease.
Select...
My child is older than 3 years.
Select...
I have been diagnosed with Cystic Fibrosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
skin conductance measurements
Secondary study objectives
Effect of single nucleotide polymorphisms in the mu-opioid receptor A118G on post-operaive pain scores

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: skin conductanceExperimental Treatment1 Intervention
The skin conductance monitor will be applied to all study patient. There is no second arm to the study

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
511 Previous Clinical Trials
2,870,680 Total Patients Enrolled
8 Trials studying Pain
463 Patients Enrolled for Pain
Priti G Dalal, MD, FRCAPrincipal InvestigatorMilton S. Hershey Medical Center

Media Library

Skin conductance monitor for measuring skin conductance Clinical Trial Eligibility Overview. Trial Name: NCT02534168 — N/A
Pain Research Study Groups: skin conductance
Pain Clinical Trial 2023: Skin conductance monitor for measuring skin conductance Highlights & Side Effects. Trial Name: NCT02534168 — N/A
Skin conductance monitor for measuring skin conductance 2023 Treatment Timeline for Medical Study. Trial Name: NCT02534168 — N/A
~16 spots leftby Dec 2025
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