Evaluation of Post-PACU Pain Management in Pediatric Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Additional face-to-face education, Standard of care management.
- Who it may be relevant to
- Registry conditions: Pain. Basic parameters: 1 year — 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Post-PACU Pain Management Experiences in Pediatric Ambulatory Surgery Patients
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.
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.
Interventions
- Other 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 - Other Standard of care management
Current standard of care at a major U.S. teaching hospital.
Primary outcome measures
- Change in Postoperative Pain Measure for Parents Score [Time frame: baseline, 72 hours, 7-14 days, up to 4 weeks]
Secondary outcome measures (4)
- Change in Postoperative Anesthesia Emergence Delirium (PAED) Score [Time frame: baseline, 72 hours, 7-14 days, up to 4 weeks]
- Change in Emotionality, Activity, Sociability, Impulsivity Instrument of child Temperament (EASI) Scale [Time frame: baseline, 72 hours, 7-14 days, up to 4 weeks]
- Change in Modified Yale Preoperative Anxiety Scale (mYPAS) [Time frame: baseline, 72 hours, 7-14 days, up to 4 weeks]
- Change in Post-Hospital Behavior Questionnaire Score [Time frame: baseline, 72 hours, 7-14 days, up to 4 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Columbia University — New York
Identifiers
NCT: NCT02352116 · AAAI5954