Pain Control in Elderly Hip Fracture Patients: Is Intravenous Acetaminophen Superior to Oral Administration?
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Pain Score
研究概览
简要总结
The primary objective is to determine if intravenous acetaminophen decreases pain scores and the amount of morphine equivalence received as compared to oral acetaminophen in patients greater than 65 years old after sustaining a hip fracture.
详细描述
Surgeons involved in this research agree to the randomization of patients into one of two groups. After informed consent, patients will be randomly assigned in a 1:1 ratio to the treatment group or the control group.
Group 1: This group will serve as the control group, and will be scheduled to receive one gram (1g) acetaminophen PO every 8 hours.
Group 2: This group will serve as the treatment group, and will be scheduled to receive one gram (1g) acetaminophen IV every 8 hours
The standardized pain control protocol for hip fracture patients will be initiated for all patients. The pain protocol will be initiated at hospital admission, and after three postoperative doses of the group assigned acetaminophen all patients will be switched to one gram scheduled acetaminophen PO in preparation for hospital discharge.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute, isolated, unilateral femoral neck, intertrochanteric, and per trochanteric hip fractures confirmed by anteroposterior/lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
- •Age ≥ 65 years.
- •Low energy mechanism.
- •Hip fracture fixation performed within 48 hours of injury.
- •English speaking.
- •Anticipated medical optimization for operative fixation.
- •No other major trauma.
排除标准
- •Unable to provide informed consent (dementia, limited decision making capacity)
- •Admitted by medical service for significant co-morbidities
- •Retained hardware around the affected hip
- •Infection around the affected hip
- •Transfer patients with a length of stay > 24 hours at the transferring hospital
- •Known allergy to acetaminophen
- •Current use of narcotics
- •Receiving a regional anesthetic block at any point during the hospitalization
- •Known history of hepatic disease (hepatitis, cirrhosis)
- •Weight < 50kg
- •Involved in another clinical trial that would interfere with the intervention of this study
研究组 & 干预措施
IV Acetaminophen
1,000mg Acetaminophen IV every 8 hours until the patient has received 3 doses post-operatively. Then 1,000mg Acetaminophen po every 8 hours until discharge.
干预措施: IV Acetaminophen (Drug)
PO Acetaminophen
1,000mg Acetaminophen po every 8 hours until discharge.
干预措施: PO Acetaminophen (Drug)
结局指标
主要结局
Pain Score
时间窗: 6 days
Pain scores will be compared between the two groups.
次要结局
- Timing of First Day of Ambulation.(6 days)
- Distance Ambulated(6 days)
- The Amount of Morphine Equivalents, as Determined by an Opioid Dose Calculator, Received by the Patient.(6 days)
- Hospital Stay(2 weeks)