Recruiting

Pain Management

Sponsor:

Columbia University

Code:

NCT02352116

Conditions

Pain

Eligibility Criteria

Sex: All

Age: 1 - 6

Healthy Volunteers: Accepted

Interventions

Additional face-to-face education

Standard of care management

Study Details

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

Study ID

NCT02352116

Start date

Jun, 2013

Status verified date

Apr, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 6

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

900 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Additional education

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

active comparator: No additional education

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

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

Standard of care management

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

Primary outcome measure

  • Change in Postoperative Pain Measure for Parents Score [ Time Frame: baseline, 72 hours, 7-14 days, up to 4 weeks ]

Central Contacts and Locations

Central contacts

Lena S. Sun, MD

212-305-2413

Locations

Columbia University

Recruiting

New York, New York, United States, 10032

Contacts

Lena Sun, MD

212-305-2413

More Information

Sponsor

Columbia University

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Keywords

  • Postoperative Experience
  • Postoperative Behavioral Changes
  • Maladaptive Behavioral Changes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-04-23.