Postoperative Pain Management in Patients Undergoing Intramedullary Nail Fixation After Tibia and Femoral Fractures
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- 12hrs VAS Pain Scores
研究概览
简要总结
The purpose of this trial is to determine whether oral acetaminophen and intravenous ketorolac are viable alternatives to opioid medication regimens for the pain management of patients with tibial and femoral shaft fractures treated with intramedullary nailing. This study will explore an alternative for opioid medications for patients undergoing intramedullary nailing of tibial and femoral shaft fractures.
详细描述
The data analysis for the study will be performed separately for patients with femoral fractures and for patients with tibial fractures. Therefore, the data analysis will compare patients with femoral fractures receiving the experimental treatment to patients with femoral fractures receiving the control treatment (Group 1 vs. Group 2). Likewise, patients with tibial fractures receiving the experimental treatment will be compared to patients with tibial fractures receiving the control treatment (Group 3 vs. Group 4).
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with tibial and femoral shaft fractures
- •Patients undergoing intramedullary nailing
- •Willing to participate in the protocol
排除标准
- •Chronic pain disorder (daily use of oral opioids)
- •Allergy or hypersensitivity to non steroid anti-inflammatory drug
- •Impaired renal, cardiac, or hepatic function
- •History of gastrointestinal bleeding or substance abuse
研究组 & 干预措施
Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and oral acetaminophen
Group 1 will be composed of tibial fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.
干预措施: Intravenous ketorolac and oral acetaminophen (Drug)
Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and oral oxycodone
Group 2 will be composed of tibial fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.
干预措施: Intravenous morphine and oral oxycodone (Drug)
Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen
Group 3 will be composed of femoral fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.
干预措施: Intravenous ketorolac and oral acetaminophen (Drug)
Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and oral oxycodone
Group 4 will be composed of femoral fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.
干预措施: Intravenous morphine and oral oxycodone (Drug)
结局指标
主要结局
12hrs VAS Pain Scores
时间窗: Measured at postoperative hour 12
Visual Analog Scale; 0-10 (10 indicates highest degree of pain)
24hrs VAS Pain Score
时间窗: Measured at postoperative hour 24
Visual Analog Scale; 0 to 10 (10 indicates highest degree of pain)
36hrs VAS Pain Scores
时间窗: Measured at postoperative hour 36
Visual Analog Scale; 0-10 (10 indicates highest degree of pain)
48hrs VAS Pain Scores
时间窗: Measured at postoperative hour 48
Visual Analog Scale; 0-10 (10 indicates highest degree of pain)
12hrs MME
时间窗: Measured at postoperative hour 12
Opioid consumption at postoperative hour 12. Reported as Morphine Milligram Equivalents (MME)
24hrs MME
时间窗: Measured at postoperative hour 24
Opioid consumption at postoperative hour 24. Reported as Morphine Milligram Equivalents (MME)
36hrs MME
时间窗: Measured at postoperative hour 36
Opioid consumption at postoperative hour 36. Reported as Morphine Milligram Equivalents (MME)
48hrs MME
时间窗: Measured at postoperative hour 48
Opioid consumption at postoperative hour 48. Reported as Morphine Milligram Equivalents (MME)
次要结局
- Hospital Length of Stay(Determined by discharge date)