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Recruiting Not applicable NCT02352116

Evaluation of Post-PACU Pain Management in Pediatric Surgery

No applicable phase (e.g. observational)
Conditions: Pain

Sponsor: Columbia University

trial.available_in: БГ
Overview
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.
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.
Who can participate
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.
Interventions
Additional face-to-face education
OTHER
Standard of care management
OTHER
Locations 1
United States (1)
Columbia University
New York , New York
Lena Sun, MD
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
1 Year
Maximum age
6 Years
Healthy volunteers
No
Start date
01.06.2013
Completion date
01.12.2027
Registry ID
NCT02352116
Source
clinicaltrials.gov
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