Randomized, Double-Blind, Study Comparing Oral Acetaminophen Plus Intravenous (IV) Placebo to Oral Placebo Plus IV Acetaminophen Given Perioperatively for Controlling Pain in the 24hr Post-op Period After Total Hip or Knee Joint Replacement
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 515
- 试验地点
- 1
- 主要终点
- Total Post-operative Use of Opioids
研究概览
简要总结
The purpose of the study is to evaluate post-op pain requirements in patients undergoing hip or knee replacement surgery who perioperatively receive either Oral acetaminophen or IV acetaminophen
详细描述
Subjects will be randomized to receive perioperative dosing of either:
- Oral acetaminophen (Tylenol) 1000mg with IV Placebo (100ml Normal Saline), OR,
- IV acetaminophen (Ofirmev) 1000mg/100ml with Oral Placebo (oral capsules).
Subject pain levels and post-operative opioid use will be tracked for up to 24 hours after surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age and older
- •Able to provide written consent
- •Able to read and write in English
- •Weighing over 50 kg
- •Will undergo total hip or total knee joint replacement
排除标准
- •Non-verbal patients
- •Unable to use numeric pain scale
- •Allergic to the test article
- •Documented hepatic impairment or failure
- •Current illicit drug use
- •Requires traumatic or emergent surgery
- •Pregnant women
- •Women who are breastfeeding
- •Prisoners
- •Cognitively impaired requiring Legally Authorized Representative (LAR) or Power of Attorney (POA)
- •Unable to swallow oral capsules
研究组 & 干预措施
Oral acetaminophen
Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.
干预措施: Oral acetaminophen (Drug)
IV acetaminophen
Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.
干预措施: IV acetaminophen (Drug)
结局指标
主要结局
Total Post-operative Use of Opioids
时间窗: During post-op period up to 24 hrs after surgery
Post-operative use of opioids, measured in morphine milligram equivalent (MME) units
次要结局
- Patient-rated Pain in the Post-operative Period(Standard-of-care post-op assessment intervals during post-op period up to 24 hrs after surgery)