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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
skin conductance measurements
Secondary outcome measures
Effect of single nucleotide polymorphisms in the mu-opioid receptor A118G on post-operaive pain scores
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
492 Previous Clinical Trials
2,798,642 Total Patients Enrolled
8 Trials studying Pain
463 Patients Enrolled for Pain
Priti G Dalal, MD, FRCAPrincipal InvestigatorMilton S. Hershey Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on a long-term pain management plan.I use painkillers before surgery.I am in good or mild systemic disease health according to the ASA.I have been diagnosed with obstructive sleep apnea.My health is severely impacted by my disease.My child is older than 3 years.My child is 0-3 years old and needs surgery to repair the palate.I have been diagnosed with Cystic Fibrosis.
Research Study Groups:
This trial has the following groups:- Group 1: skin conductance
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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