Evaluation of Post-PACU Pain Management in Pediatric Surgery
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Additional face-to-face education, Standard of care management.
- Кому может быть актуально
- Состояния в реестре: Pain. Базовые параметры: 1 год — 6 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Evaluation of Post-PACU Pain Management Experiences in Pediatric Ambulatory Surgery Patients
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое 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 - Другое Standard of care management
Current standard of care at a major U.S. teaching hospital.
Первичные конечные точки
- Change in Postoperative Pain Measure for Parents Score [Срок оценки: baseline, 72 hours, 7-14 days, up to 4 weeks]
Вторичные конечные точки (4)
- Change in Postoperative Anesthesia Emergence Delirium (PAED) Score [Срок оценки: baseline, 72 hours, 7-14 days, up to 4 weeks]
- Change in Emotionality, Activity, Sociability, Impulsivity Instrument of child Temperament (EASI) Scale [Срок оценки: baseline, 72 hours, 7-14 days, up to 4 weeks]
- Change in Modified Yale Preoperative Anxiety Scale (mYPAS) [Срок оценки: baseline, 72 hours, 7-14 days, up to 4 weeks]
- Change in Post-Hospital Behavior Questionnaire Score [Срок оценки: baseline, 72 hours, 7-14 days, up to 4 weeks]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Тройное слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 1 центр
- Columbia University — New York
Идентификаторы
NCT: NCT02352116 · AAAI5954