Assessment of Postoperative Pain Outcomes Following Pediatric Adenotonsillectomy and the Impact on Non-Steroidal Anti-Inflammatory Drugs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Incidence of severe postoperative pain
研究概览
简要总结
This prospective observational study will evaluate postoperative pain after outpatient pediatric adenotonsillectomy in adolescents prescribed either acetaminophen with ibuprofen or acetaminophen with oral ketorolac after discharge, based on the prescribing preference of the otolaryngology surgeon. Participants will complete text-message surveys after discharge to assess pain severity, medication administration, and functional recovery for up to 14 days.
详细描述
Adenotonsillectomy is commonly associated with significant postoperative pain lasting 10-14 days. As opioid prescribing after adenotonsillectomy has decreased, non-opioid regimens using acetaminophen with either ibuprofen or ketorolac are increasingly used. However, post-discharge pain outcomes with oral ketorolac are not well described. This study will compare postoperative pain experience, severe pain incidence, medication use, functional recovery, and healthcare utilization after discharge among patients receiving acetaminophen plus ibuprofen versus acetaminophen plus low-dose oral ketorolac as part of routine care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for outpatient adenotonsillectomy Age 13-18 years ASA physical status I-III Patient or parent has access to a phone with text-messaging capability Patient assent Parent or legal guardian consent
排除标准
- •Inpatient admission or planned 23-hour observation Known hematologic condition or prior bleeding disorder Current anticoagulant use Known or suspected chronic kidney disease or solitary kidney Known or suspected liver disease or prior liver transplant Known or suspected mitochondrial disease or genetic anomaly Inability to self-report pain History of gastrointestinal ulcer or bleeding Allergy to acetaminophen, ibuprofen, or ketorolac Non-English or non-Spanish speaking Chronic pain or condition requiring frequent routine NSAID use Patient refusal Parent or guardian refusal
研究组 & 干预措施
Cohort 1: Acetaminophen + Ibuprofen
Participants prescribed acetaminophen and ibuprofen after discharge according to routine clinical practice.
Cohort 2: Acetaminophen + Oral Ketorolac
Participants prescribed acetaminophen and low-dose oral ketorolac after discharge according to routine clinical practice.
结局指标
主要结局
Incidence of severe postoperative pain
时间窗: Postoperative days 1-10
Pain score measured using the 0-10 Numeric Rating Scale after adenotonsillectomy.
Incidence of severe postoperative pain
时间窗: Postoperative days 1, 3, 5, 7, 10
Pain score measured using the 0-10 Numeric Rating Scale after adenotonsillectomy.
次要结局
- Incidence of severe postoperative pain(Postoperative days 1-10)
- Incidence of severe postoperative pain(Postoperative days 1, 3, 5, 7, 10)
研究者
Adam Adler MD, MS, FAAP
Professor of Anesthesiology and Surgery
Baylor College of Medicine