Oxycodone or Ibuprofen for Suspected Isolated Forearm Fractures in Pediatric Patients: A Randomized Noninferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 200
- 主要终点
- Pain change/difference
研究概览
简要总结
Children presenting to the Emergency Room with the chief complaint of forearm injury and/or pain will be randomized to receive oral Oxycodone or Ibuprofen to control pain.
详细描述
A randomized, blinded cohort study. Consented patients will be randomized to receive either ibuprofen or oxycodone after initial RN patient assessment in Emergency Department Triage determines a need for radiographs to evaluate for possible forearm fracture. Pain assessment scores will be determined at Triage and at 30-minute intervals throughout the patient's course until the patient is discharged home or additional analgesic medication is administered.
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6 to 17 year old children presenting for care in the St. Louis Children's Hospital Emergency Department
- •Suspected acute (within 24 hours) isolated forearm fracture at the time of initial Triage assessment
- •American Society of Anesthesiologist physical status (ASA-PS) classification of I or II
- •Child with parent or legal guardian.
排除标准
- •Multiple injuries
- •Known adverse reaction to either ibuprofen or oxycodone pts with abnormal bones or metabolic conditions that affect bones
- •Administration of any opioid within 2 hours prior to presentation
- •Non-English speaking
- •Foster care, police custody, presenting without legal guardian
研究组 & 干预措施
Ibuprofen Group
To compare analgesia from ibuprofen to oxycodone in the initial treatment of acute pain in suspected isolated forearm fractures in children.
干预措施: Ibuprofen (Drug)
Oxycodone Group
To compare analgesia from ibuprofen to oxycodone in the initial treatment of acute pain in suspected isolated forearm fractures in children.
干预措施: Oxycodone (Drug)
结局指标
主要结局
Pain change/difference
时间窗: 180 minutes total
An appreciable change in pain scores (by 2 points) from presentation to discharge
次要结局
未报告次要终点