Evaluation of Post-PACU Pain Management in Pediatric Surgery

NCT ID: NCT02352116

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2026-12-31

Brief Summary

This study aims to assess the differences in overall pain severity, pain management, and satisfaction during recovery period between two groups of children who either receive or do not receive additional education related to expectation and management of postoperative pain.

Detailed Description

With the increased frequency and popularity of pediatric ambulatory surgery, there is a greater need for evaluation of the postoperative pain experience after discharge from the hospital. Pain is one of the most significant factors affecting the postoperative experience in adults, and also be true in the pediatric population. Control of postoperative pain in children after discharge from the hospital poses particular challenges due to dependence on parental or caretaker ability to properly evaluate the child's pain, their understanding of appropriate dosing of pain medications, and their willingness to administer enough medications until sufficient relief is achieved.

The investigators aim to assess the differences in reported pain between groups who receive additional face-to-face education versus the current standard of care at a major US teaching hospital. The study will assess pain management after surgery using parental reports and questionnaires to assess their child's pain at multiple time points during the study. Additionally, this study will also assess baseline behavioral attributes of children and will compare behavioral changes at 24-48 hours, 7-10 days, and 2-4 weeks postoperatively as these behavior changes may also affect overall postoperative experience.

This study is divided into phase I and phase II. Phase I is the initial assessment of the investigators' institution's pain management in healthy pediatric patients undergoing ambulatory surgical procedures. Phase II consists of randomized trial which includes a randomized intervention group and control group. The group selected randomly for intervention will receive additional teaching regarding what to expect in terms of postoperative pain and how to properly identify pain in children.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Additional education

Subjects undergoing ambulatory surgery who receive standard of care management with additional face-to-face education in postoperative pain management.

Group Type: EXPERIMENTAL

Additional face-to-face education

Intervention Type: OTHER

Additional teaching regarding what to expect in terms of postoperative pain, how to properly identify pain in children, and instruction on the proper administration of analgesic medications

Standard of care management

Intervention Type: OTHER

Current standard of care at a major U.S. teaching hospital.

No additional education

Subjects undergoing ambulatory surgery who receive standard of care management with no additional education in postoperative pain management.

Group Type: ACTIVE_COMPARATOR

Standard of care management

Intervention Type: OTHER

Current standard of care at a major U.S. teaching hospital.

Interventions

Additional face-to-face education

Additional teaching regarding what to expect in terms of postoperative pain, how to properly identify pain in children, and instruction on the proper administration of analgesic medications

Intervention Type: OTHER

Standard of care management

Current standard of care at a major U.S. teaching hospital.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients ages 1-6 years undergoing ambulatory surgical procedures.
• Patients with an ASA status of I or II spending 23 hours or less recovering in the PACU and discharged home.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Lena S. Sun

Emanuel M. Papper Professor of Anesthesiology and Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lena S. Sun, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lena S. Sun, MD

Role: CONTACT

212-305-2413

Facility Contacts

Lena Sun, MD

Role: primary

212-305-2413

Other Identifiers

AAAI5954

Identifier Type: -

Identifier Source: org_study_id