Intravenous Acetaminophen as Adjuvant Therapy for Pain Control in Geriatric Hip Fracture Patients
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Opioid usage
研究概览
简要总结
This research study is a prospective, randomized, blinded, placebo controlled trial evaluating the benefit of IV acetaminophen (Ofirmev™) as adjuvant analgesia in geriatric hip fracture patients. IV acetaminophen has received FDA approval. IV acetaminophen does not have the liver toxicity as oral acetaminophen. No oral acetaminophen will be administered. All patients diagnosed with a hip fracture aged at least 65 years and expected to undergo surgical intervention are eligible to participate. Hip fractures affect greater than 300,000 geriatric patients annually, representing the second leading cause of hospitalization for this patient population. Pain control in these patients is often problematic due to co-morbidities and changes in their pharmacokinetic and pharmacodynamic profiles. Subjects may receive the normal DVT prophylactic treatments post-op.
详细描述
Approximately 46 subjects will be enrolled at LGH. Subjects will be randomized 1:1 to receive either IV acetaminophen 1000 mg q6 hours (FDA recommended dose) or IV placebo. While receiving the study drug/placebo the subject's blood pressure, heart rate, respiratory rate, & pain intensity will be monitored. Additional pain meds will be given if needed. Study treatment will continue until subject is taken into the operating room; at that time the intervention will be discontinued and other pain medication will be provided. Participation in the study will end at time of discharge from the hospital. Researchers are expecting a 33% decrease in opioid use for subjects randomized to treatment group.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients aged at least 65 years with a diagnosis of hip fracture with whom surgical intervention is expected
- •Patients with the following surgeons ( David Hughes MD, Gerald Rothacker MD, Frank Essis MD, James Carson MD, Michael Gish MD, Vincent Battista MD)
排除标准
- •Documented drug or alcohol addiction or abuse
- •Documented serum sodium levels > 145 mmol/L
- •Documented serum chloride levels > 107 mmol/L
- •Impaired liver function defined as an ALT or AST > 3 times the upper limit of normal, Child-Pugh class C, or patients with documented active liver disease
- •Known allergy or intolerance to acetaminophen
- •Weight ≤ 50 kg
- •Creatinine clearance (CrCl) ≤ 30 ml/min as determined by the Cockcroft-Gault equation
- •Documented dementia
- •Acetaminophen (> 650 mg) or opioid (> 7 mg IV morphine equivalence) use within the previous 24 hours
- •Documented chronic opioid use
研究组 & 干预措施
Placebo
For the control group, a total of 100 mLs of 0.9% sodium chloride will be transferred to a Hospira LifeCare container and infused over 15 minutes (6.7 mL/min). A beyond use expiration of 6 hours will be placed on the container.
干预措施: Placebo (Drug)
Acetaminophen treatment
For the treatment group, a total of 100 milliliters (mLs) of acetaminophen (1000 mg) will be transferred to a Hospira LifeCare container and infused over 15 minutes (6.7 mLs/min). A beyond use expiration of 6 hours at room temperature will place on the container, as recommended by the manufacturer.
干预措施: Acetaminophen IV (Drug)
结局指标
主要结局
Opioid usage
时间窗: 24 Hours
Participants will be assessed for opioid utilization until they go to surgery: an average of 24 hours.
次要结局
- Length of stay(Up to 1 week)
- Vital signs(Up to 1 week)
- Opioid induced side effects(Up to 1 week)
- Pain scores(Up to 1 week)
研究者
Michael A. Horst, PhD, MPHS, MS
Director of Research
Lancaster General Hospital