Effectiveness of a Combined Acetaminophen and Ibuprofen Regimen for Management of Post-Tonsillectomy Pain in Pediatric Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 3
研究概览
简要总结
Single-center, randomized, open-label, non-inferiority treatment pilot study to evaluate the effectiveness of a combined acetaminophen and ibuprofen regimen for treatment of post-operative tonsillectomy pain in the pediatric population. 100 children undergoing tonsillectomy will be randomized to receive either a combined acetaminophen and ibuprofen regimen dosed every 6 hours or an alternating regimen of acetaminophen and ibuprofen dosed every 3 hours.
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
盲法说明
Open-label
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •4 to 17 years of age at time of enrollment
- •Undergoing tonsillectomy with or without adenoidectomy
- •Able to provide informed consent from parent or legal guardian
- •Able to provide assent if subject is a minor of appropriate age
排除标准
- •Allergy to acetaminophen or ibuprofen
- •Inability for study participant to cooperate with pain assessments
- •Known pregnancy
- •Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
研究组 & 干预措施
Alternating Regimen
A regimen of acetaminophen and ibuprofen alternating doses every 3 hours.
干预措施: Alternating Acetaminophen and Ibuprofen (Drug)
Combined Regimen
A regimen of acetaminophen and ibuprofen dosed together every 6 hours.
干预措施: Combined Acetaminophen and Ibuprofen (Drug)
结局指标
主要结局
Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 3
时间窗: up to 3 days following consent
The proportion of FLACC (Faces, Legs, Activity, Cry, and Consolability scale) pain scores ≥7 from POD 1 through POD 3 compared between the combined and the alternating medication regimens. The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2.
次要结局
- Number of Participants With Rescue Medication Usage Through POD 3(up to 3 days following consent)
- Number of Participants With Faces Pain Scores ≥8 on POD 1, 3, and 7(3 separate individual days, will be completed days after the surgery)
- Adverse Events(up to 7 days following consent)
- Number of Participants With FLACC Pain Scores ≥7 on Each Individual POD 1, 3, and 7(3 separate individual days, will be completed days after the surgery)
- Number of Participants With Cumulative Faces Pain Scores ≥8 From POD 1 Through POD 7(up to 7 days following consent)
- Number of Participants With Rescue Medication Usage Through POD 7(up to 7 days following consent)
- Proportion of Subjects That Adhere to the Assigned Medication Regimen(up to 3 days following consent)
- Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 7(up to 7 days following consent)