A Randomized Controlled Trial of Opioid vs Non-Opioid Postoperative Pain Management in Children With Supracondylar Humerus Fractures
概览
- 阶段
- 4 期
- 干预措施
- Ibuprofen
- 疾病 / 适应症
- Supracondylar Humerus Fracture
- 发起方
- Baylor College of Medicine
- 入组人数
- 29
- 试验地点
- 3
- 主要终点
- Daily Pain Scores on the FACES Scale
- 状态
- 终止
- 最后更新
- 2个月前
概览
简要总结
There are two common and concurrently used strategies for pain management following surgical treatment of supracondylar humerus (elbow) fractures in children: opioids vs over the counter pain medications. The purpose of this study is to determine if ibuprofen and acetaminophen can provide similar or better pain relief compared to ibuprofen and hydrocodone/acetaminophen (also known as Hycet) for this population of children after they have been discharged. If over the counter medications can provide adequate pain relief, then fewer opioid prescriptions would be necessary. This reduces early opioid exposure and decreases unnecessary opioids in circulation.
详细描述
Prior to surgery, participants will be randomly assigned to a group that will determine whether they are prescribed an opioid vs non-opioid pain management plan at discharge. Each participants' parent or guardian will be given a journal to keep track of their child's pain severity and the pain medications taken. The journal will updated daily until participants no longer require pain medication. Participants will follow up with their surgeon per usual at their post-operative visits.
研究者
Scott Rosenfeld
Associate Professor of Orthopaedic Surgery
Baylor College of Medicine
入排标准
入选标准
- •Closed, Gartland type III supracondylar humerus fracture
- •Fractures treated with closed reduction and percutaneous pinning (CRPP)
- •Patients expected to follow up at Texas Children's Hospital
- •Patients/guardians must speak English or Spanish
排除标准
- •Fractures associated with open skin wounds, polytrauma, neurologic deficit, or vascular deficit
- •Patients who have impaired ability to report pain severity such as intellectual delay.
- •Patients who have a problem with bone healing such as osteogenesis imperfecta.
- •Patients who are unable to take the standard dose of acetaminophen, ibuprofen, or hydrocodone (allergy, severe kidney disease, etc).
- •Patients who are on chronic NSAID or opioid medication prior to injury.
- •Patients with injury from suspected non-accidental trauma.
研究组 & 干预措施
Opioid Pain Management
Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Hydrocodone/Acetaminophen (liquid, 0.135mg Hydrocodone/kg/dose every 6 hours) will be used as needed for breakthrough pain.
干预措施: Ibuprofen
Opioid Pain Management
Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Hydrocodone/Acetaminophen (liquid, 0.135mg Hydrocodone/kg/dose every 6 hours) will be used as needed for breakthrough pain.
干预措施: Hydrocodone/acetaminophen
Non-Opioid Pain Management
Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Acetaminophen (liquid, 15mg/kg/dose every 6 hours) will be used as needed for breakthrough pain.
干预措施: Ibuprofen
Non-Opioid Pain Management
Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Acetaminophen (liquid, 15mg/kg/dose every 6 hours) will be used as needed for breakthrough pain.
干预措施: Acetaminophen
结局指标
主要结局
Daily Pain Scores on the FACES Scale
时间窗: from discharge until pain medication is no longer required (assessed up to 3 weeks)
A parent/guardian will ask participants to rate their pain severity using the Wong-Baker FACES scale, which ranges from 0 (no pain) to 10 (worst pain).
次要结局
- Number of Days Pain Medication Required(from discharge until pain medication is no longer required (assessed up to 3 weeks))
- Number of Pain Medication Doses Required Per Day(from discharge until pain medication is no longer required (assessed up to 3 weeks))