Evaluation of Post-PACU Pain Management in Pediatric Surgery

NCT02352116 | Recruiting

• 1 other identifier: AAAI5954
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Postoperative Experience; Postoperative Behavioral Changes; Maladaptive Behavioral Changes

Outcome Measures

Primary Outcomes (1)

• Change in Postoperative Pain Measure for Parents Score

  Validated questionnaire for parental assessment of pain in children ages 1-12 years

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

Secondary Outcomes (4)

• Change in Postoperative Anesthesia Emergence Delirium (PAED) Score

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

• Change in Emotionality, Activity, Sociability, Impulsivity Instrument of child Temperament (EASI) Scale

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

• Change in Modified Yale Preoperative Anxiety Scale (mYPAS)

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

• Change in Post-Hospital Behavior Questionnaire Score

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

Study Arms (2)

Additional education

EXPERIMENTAL

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

Other: Additional face-to-face education; Other: Standard of care management

No additional education

ACTIVE COMPARATOR

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

Other: Standard of care management

Interventions

Additional face-to-face education 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

Additional education

Standard of care management OTHER

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

Additional education; No additional education

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lena S. Sun, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lena S. Sun, MD

CONTACT

212-305-2413

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emanuel M. Papper Professor of Anesthesiology and Professor of Pediatrics

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: February 2, 2015
• Study Start: June 1, 2013
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (1)