Ibuprofen Versus Acetaminophen With Codeine In Acute Pediatric Forearm Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 335
- 试验地点
- 1
- 主要终点
- Change to rescue medication
研究概览
简要总结
A clinical trial comparing ibuprofen and acetaminophen with codeine for children after discharge from the emergency department. We hypothesize that Ibuprofen will provide 20% more effective analgesia compared to acetaminophen with codeine in children with uncomplicated forearm fractures.
详细描述
A clinical trial comparing ibuprofen and acetaminophen with codeine for children after discharge from the emergency department. We hypothesize that Ibuprofen will provide 20% more effective analgesia compared to acetaminophen with codeine in children with uncomplicated forearm fractures. A random table will be used to generate an assignment of the participants to either ibuprofen or acetaminophen with codeine. Assessment of the child's pain severity, pain medication use, functional limitations and parental satisfaction will allow for identification of a difference in the management of pain in the first 72 hours after a forearm fracture. Descriptive statistics will be used to analyze demographic data.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children ages 4-18 years of age with an uncomplicated forearm fracture that is evaluated within 12 hours of injury and requires only splinting
排除标准
- •A history of a bleeding disorder, uncontrolled chronic medical disease, regularly use of or allergy to acetaminophen, ibuprofen, or codeine or developmental delay
研究组 & 干预措施
Ibuprofen
干预措施: ibuprofen (Drug)
acetamin w codeine
干预措施: acetamin w codeine (Drug)
结局指标
主要结局
Change to rescue medication
时间窗: First 72 hours after ED discharge
次要结局
- Pain score(First 72 hours after ED discharge)
- Functional outcomes: eat, sleep, play, school(First 72 hours after ED discharge)