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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.

Must not have

Patients with an ASA status of III or IV.

Patients admitted as inpatients or transferred to the PICU or inpatient for recovery, and any conditions that may affect pain expression or sensation.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 72 hours, 7-14 days, up to 4 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I am in good or fair health and will spend less than a day in recovery after surgery before going home.

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I am between 1 and 6 years old and scheduled for a minor surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My health status is severely or critically impaired.

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I am hospitalized or in intensive care, which might affect how I feel or show pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 72 hours, 7-14 days, up to 4 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Postoperative Pain Measure for Parents Score

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,486 Previous Clinical Trials

2,662,290 Total Patients Enrolled

12 Trials studying Pain

1,017 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.