Comparing Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Parental pain control satisfaction using Parental Post-operative Pain Measure (PPPM)
研究概览
简要总结
There is concern that pain prescription after outpatient pediatric surgical procedures is excessive and is in excess of patient need. Current practice following pediatric appendectomy is to prescribe all children with 5-15 doses of narcotic pain medication upon discharge regardless of their age, severity of appendicitis, or pain control in the hospital. This study examines the amount of narcotic pain control required by pediatric patients after undergoing appendectomy using a randomized controlled trial study design.
Pain control will be assessed with a post-operative pain scale, patient satisfaction survey, and parent satisfaction survey on the days following surgery and at post-operative follow-up.
The hypothesis is that the pain scores and patient satisfaction surveys will show no difference in post-operative pain control between the two arms.
详细描述
There is concern that pain prescription after outpatient pediatric surgical procedures is excessive and is in excess of patient need. Current practice following pediatric appendectomy is to prescribe all children with 5-15 doses of narcotic pain medication upon discharge regardless of their age, severity of appendicitis, or pain control in the hospital. This study examines the amount of narcotic pain control required by pediatric patients after undergoing appendectomy using a randomized controlled trial study design.
Children admitted after undergoing surgical management for a diagnosis of acute appendicitis will be randomized at discharge to a narcotic arm or a tylenol/motrin arm. The narcotic arm will receive the standard of care narcotic prescription. The tylenol/motrin arm will receive education to use tylenol and motrin for pain control as well as a paper prescription provided for the sole purpose of rescue.
Pain control will be assessed with a post-operative pain scale, patient satisfaction survey, and parent satisfaction survey on the days following surgery and at post-operative follow-up.
The hypothesis is that the pain scores and patient satisfaction surveys will show no difference in post-operative pain control between the two arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ages 0 to 18 years old
- •Patients have undergone appendectomy by any technique (open, laparoscopic, single-port)
排除标准
- •Patients on chronic opioids
- •Patient undergoes a more extensive or additional procedures at the time of operation due to complications or other indication
- •Pregnancy
研究组 & 干预措施
Tylenol/Motrin
Group of patients who will receive instructions to use tylenol and motrin for pain control, and parents will be sent home with a paper prescription with a rescue does of standard of care narcotics. They will be instructed to only use the rescue dose if pain is uncontrolled using over the counter medications.
干预措施: Non-narcotic pain control (Drug)
结局指标
主要结局
Parental pain control satisfaction using Parental Post-operative Pain Measure (PPPM)
时间窗: 2-week follow-up visit
Parental satisfaction with pain control at home following pediatric appendectomy as assessed by the validated Parental Post-operative Pain Measure (PPPM)
次要结局
- Patient pain control satisfaction using adaptation of Parental Post-operative Pain Measure (PPPM)(Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up)
- Parental pain control satisfaction using Parental Post-operative Pain Measure (PPPM)(Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up)
- Days of pain medication requirement after discharge(Post-operative days 1-14 (until follow-up))
- Number of pain medication side effects(Post-operative days 1-14 (until follow-up))
- Patient pain scores using Wong-Baker Faces Pain Rating Scale(Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up)
- Number of pain medications used(Post-operative days 1-14 (until follow-up))
研究者
Sean Stokes
General Surgery Resident
University of Utah