Comparing the Difference in Pain Control in the Pediatric General Surgery Population: to Alternate or Combine Acetaminophen and Ibuprofen?
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain Visual Analog Scale (VAS)
研究概览
简要总结
To examine the difference in pain control in the pediatric general surgery population alternating acetaminophen and Ibuprofen q 3 hours vs giving them simultaneous combination therapy around the clock.
详细描述
The purpose of the study is to compare the difference in pain control in the pediatric general surgery population of those who receive alternating acetaminophen and ibuprofen every 3 hours to those who receive acetaminophen and ibuprofen combined therapy around the clock. Additionally, to investigate the difference in parent adherence to pain treatment plans between the alternating group from the combined group.
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
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age group: 3 years to 18 years
- •General surgery service (hernia, appendectomy, chole, circumcision, wounds, vacs, implanted central line, etc.)
排除标准
- •Patients who are allergic to acetaminophen and/or ibuprofen
- •Patients being evaluated by SANE or evaluated for nonaccidental trauma
- •Patients admitted post-op
- •The study will take place at McLane Children's Hospital Temple Market. Patients who are pregnant.
研究组 & 干预措施
Group A
Group A will prescribe study participants in group 1 acetaminophen and ibuprofen alternating treatment every three hours. The dosage will be weight-based.
干预措施: Acetaminophen (Drug)
Group A
Group A will prescribe study participants in group 1 acetaminophen and ibuprofen alternating treatment every three hours. The dosage will be weight-based.
干预措施: Ibuprofen (Drug)
Group B
Group B will be prescribed acetaminophen and ibuprofen combined treatment every 6 hours. The dosage will be weight-based.
干预措施: Acetaminophen (Drug)
Group B
Group B will be prescribed acetaminophen and ibuprofen combined treatment every 6 hours. The dosage will be weight-based.
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Pain Visual Analog Scale (VAS)
时间窗: 24, 48, and 72 hours after surgery
This tool portrays a 10cm ruler visual and the patient selects the marker indicating their pain intensity, 0 indicating no pain to 10 indicating the worst pain possible.
Numeric Pain Rating Scale (NPRS)
时间窗: 24, 48, and 72 hours after surgery
The NPRS is scored on an 11-point scale where the higher the number indicating severe more the pain.
Faces, Legs, Activity, Cry, and Consolability (FLACC) pain assessment scale.
时间窗: 24, 48, and 72 hours after surgery
Pain will be assessed using an age-appropriate pain rating scale. The FLACC is an interval scale quantifying pain behavior with scores ranging from 0 no pain behaviors to 10 most possible pain behaviors. The five categories of behaviors assessed with the FLAC include facial expressions, leg movement, activity, crying, and consolability.
次要结局
- Parent/ guardian adherence(72 hours after surgery)
研究者
Marlene Porter
Principal Investigator
Baylor Research Institute