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NCT Number: NCT02352116

Evaluation of Post-PACU Pain Management in Pediatric Surgery

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.

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Key information

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University

New York, 10032, United States

Location status: Recruiting

Location contact

Lena Sun, MD

CONTACT

212-305-2413

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Standard of care management

Other

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

Primary outcomes

  1. Change in Postoperative Pain Measure for Parents Score

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

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

Secondary outcomes

  1. Change in Postoperative Anesthesia Emergence Delirium (PAED) Score

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

    Validated 5-question survey completed by nurses after arrival in the post-operative anesthesia unit

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

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

    The EASI is a parent report form that assesses a child's baseline temperament and yields subscales including emotionality and activity level.

    The scale contains 14 items to which participants respond on a 5- point Likert scale ranging from "Strongly disagree" to "Strongly agree". Higher scores indicate greater emotionality.

  3. Change in Modified Yale Preoperative Anxiety Scale (mYPAS)

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

    An observational measure of children's preoperative anxiety. Contains 27 items that measure activity, emotional expressivity, state of arousal, vocalization, use of parents. This must be administered by trained research assistants. Validated for children ages 2 and older

  4. Change in Post-Hospital Behavior Questionnaire Score

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

    A validated questionnaire to be completed by the parents. This measure contains 27 items that evaluate a child's general anxiety, separation anxiety, anxiety about sleep, easting disturbance, aggression toward authority, and apathy/withdrawal

Study contacts

Contact information is provided by the study sponsor or research team.

Lena S. Sun, MD

CONTACT

212-305-2413

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Evaluation of Post-PACU Pain Management Experiences in Pediatric Ambulatory Surgery Patients

Important dates

Study start
2013
Primary completion
2027
Study completion
2027
First posted
Feb 2, 2015
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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