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Enhanced Pain Education for Post-Surgery Pain in Children

N/A
Recruiting
Led By Lena Sun, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with an ASA status of I or II spending 23 hours or less recovering in the PACU and discharged home.
Patients ages 1-6 years undergoing ambulatory surgical procedures.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 72 hours, 7-14 days, up to 4 weeks
Awards & highlights

Study Summary

This trial looks at whether kids recover better when they know what to expect and how to manage their pain after surgery.

Who is the study for?
This trial is for children aged 1-6 years who are undergoing day surgery and have a low risk of complications (ASA status I or II). It's not suitable for kids with more serious health issues (ASA III or IV), those staying in the hospital overnight, or those with conditions affecting pain sensation.Check my eligibility
What is being tested?
The study compares standard post-surgery pain management to the same care plus extra education on what kind of pain to expect and how it will be managed. The goal is to see if additional information improves pain outcomes and satisfaction during recovery.See study design
What are the potential side effects?
Since this trial involves standard care and educational components, there are no direct side effects from medications being tested. However, general risks associated with postoperative care may still apply.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am in good or fair health and will spend less than a day in recovery after surgery before going home.
Select...
I am between 1 and 6 years old and scheduled for a minor surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 72 hours, 7-14 days, up to 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 72 hours, 7-14 days, up to 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Postoperative Pain Measure for Parents Score
Secondary outcome measures
Change in Emotionality, Activity, Sociability, Impulsivity Instrument of child Temperament (EASI) Scale
Change in Modified Yale Preoperative Anxiety Scale (mYPAS)
Change in Post-Hospital Behavior Questionnaire Score
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Additional educationExperimental Treatment2 Interventions
Subjects undergoing ambulatory surgery who receive standard of care management with additional face-to-face education in postoperative pain management.
Group II: No additional educationActive Control1 Intervention
Subjects undergoing ambulatory surgery who receive standard of care management with no additional education in postoperative pain management.

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,426 Previous Clinical Trials
2,472,908 Total Patients Enrolled
12 Trials studying Pain
1,018 Patients Enrolled for Pain
Lena Sun, MDPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
210 Total Patients Enrolled
Lena S. Sun, MD4.9390 ReviewsPrincipal Investigator - Columbia University
VA New York Harbor Healthcare System - Brooklyn Campus
Medical School - State University of New York, Downstate Medical Center, Doctor of Medicine
State University of New York, Downstate Medical Center, Residency in Dermatology
2 Previous Clinical Trials
510 Total Patients Enrolled
5Patient Review
I was pleased with the friendliness and helpfulness of everyone I came into contact with. I didn't have to wait at all to be seen. My yearly skin exam and related issue were taken care of quickly and efficiently in the same visit.

Media Library

Standard of care management Clinical Trial Eligibility Overview. Trial Name: NCT02352116 — N/A
Pain Research Study Groups: No additional education, Additional education
Pain Clinical Trial 2023: Standard of care management Highlights & Side Effects. Trial Name: NCT02352116 — N/A
Standard of care management 2023 Treatment Timeline for Medical Study. Trial Name: NCT02352116 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial still open to new participants?

"Affirmative. Per the information on clinicaltrials.gov, this experimental therapy is currently recruiting participants and has been since June 1st 2013; data was last refreshed on October 17th 2022. 900 volunteers are expected to join the trial at a single site of enrollment."

Answered by AI

Which demographic is most suitable for participation in this research?

"A total of 900 children aged 1-6 years with pain will be admitted in this trial. The requirements for participation include a status of ASA I or II, an ambulatory surgical procedure, and the completion of less than 23 hours recovery time in PACU before being sent home."

Answered by AI

What is the scope of enrolment for this clinical trial?

"Absolutely. According to clinicaltrials.gov, this medical trial was first posted on June 1st 2021 and is currently searching for 900 individuals from one site. The data has been recently refreshed on October 17th 2022."

Answered by AI

Does the eligibility requirements for this trial extend to adults?

"This clinical trial is recruiting pediatric patients of over 1 year and up to 6 years in age."

Answered by AI
~178 spots leftby Dec 2026