Clinical trial NCT02352116: Evaluation of Post-PACU Pain Management in Pediatric Surgery
Official title: Evaluation of Post-PACU Pain Management Experiences in Pediatric Ambulatory Surgery Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Keywords: Postoperative Experience
Postoperative Behavioral Changes
Maladaptive Behavioral Changes
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2015-02-02
Enrollment: 900
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in Postoperative Pain Measure for Parents Score
timeFrame: baseline, 72 hours, 7-14 days, up to 4 weeks
Secondary outcomes:
measure: Change in Postoperative Anesthesia Emergence Delirium (PAED) Score
timeFrame: baseline, 72 hours, 7-14 days, up to 4 weeks
measure: Change in Emotionality, Activity, Sociability, Impulsivity Instrument of child Temperament (EASI) Scale
timeFrame: baseline, 72 hours, 7-14 days, up to 4 weeks
measure: Change in Modified Yale Preoperative Anxiety Scale (mYPAS)
timeFrame: baseline, 72 hours, 7-14 days, up to 4 weeks
measure: Change in Post-Hospital Behavior Questionnaire Score
timeFrame: baseline, 72 hours, 7-14 days, up to 4 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Lena S. Sun, MD
role: PRINCIPAL_INVESTIGATOR
References: