Post-operative Pain Management in Supracondylar Humerus Fractures: A Randomized, Double-blinded, Prospective Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pain Scores
研究概览
简要总结
The purpose of this study is to determine if using the combination of acetaminophen (also known as Tylenol) and ibuprofen (also known as Motrin or Advil) will provide equal or better pain control as compared to acetaminophen-hydrocodone (also known as Lortab), in children with broken elbows who need surgery. This study will examine whether the combination of acetaminophen and ibuprofen can provide pain control as well as or better than acetaminophen-hydrocodone so that doctors might be able to prescribe less acetaminophen-hydrocodone (which can be addictive) to children in the future. Currently, the standard of care for pain control following this kind of elbow surgery is acetaminophen-hydrocodone.
详细描述
For this study, participants will be randomized (randomly assigned) to either receive scheduled acetaminophen-hydrocodone (which is the current standard of care treatment) or acetaminophen and ibuprofen (the experimental treatment) for post operative pain control following surgery for supracondylar humerus fracture. Patients in the experimental treatment group who require 2 doses of breakthrough pain medication in a row in order to control their pain will be switched to the standard of care treatment. Follow up information regarding outcomes post-discharge will be collected via secure email or text 48-72 hours post-discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 4 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •isolated supracondylar humerus fracture
- •undergoing closed reduction with percutaneous pinning (CRPP)
排除标准
- •Allergies to acetaminophen, ibuprofen, and/or acetaminophen-HYDROcodone
- •Liver or renal disease
- •history of bleeding disorder
- •medical diagnosis of juvenile arthritis
- •on chronic NSAIDs or Opioids PRIOR to the procedure
- •medical diagnosis of coagulopathies, open fractures, other injuries at time of diagnosis (multi-system trauma)
- •vascular compromise and/or compartment syndrome upon admission
研究组 & 干预措施
Control
Standard of care- weight based dose of liquid acetaminophen-hydrocodone- 0.15 mg/kg/dose every six hours with a max dose of 10 mg/dose
干预措施: Acetaminophen-Hydrocodone (Drug)
Treatment
Weight based dose of liquid acetaminophen and ibuprofen- acetaminophen 15 mg/kg/dose and ibuprofen 10 mg/kg/dose every six hours with a max dose of 650 mg/dose of acetaminophen and 600 mg/dose of ibuprofen.
干预措施: Acetaminophen and Ibuprofen (Drug)
结局指标
主要结局
Pain Scores
时间窗: 24 hours (duration of post-operative stay)
Pain scores during postoperative hospital stay on a Wong-Baker Faces scale. 0 (No Pain) to 10 (Worst pain).
次要结局
未报告次要终点
研究者
Lindsey Locke
Pediatric Nurse Practitioner
Le Bonheur Children's Hospital