A Randomized Study Comparing Intravenous (IV) Acetaminophen to Usual Care for Pain Management for Small Bowel Obstruction - Feasibility Study
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Resolution of small bowel obstruction
研究概览
简要总结
The purpose of this study is to compare IV Acetaminophen for pain control to the usual care with opioids in patients admitted for small bowel obstruction.
详细描述
The primary aim of this study is to assess the feasibility of conducting a randomized trial involving intravenous acetaminophen for pain control compared to usual care with opioids in patients admitted for small bowel obstruction and to summarize pain scores up to 72 hours after treatment. Patients presented and diagnosed with small bowel obstruction (SBO) will be screened for eligibility and will be offered participation in this study. Patients admitted for SBO for medical management with pain on admission will be eligible to participate in study. This will include patients with malignant and nonmalignant SBO. Participants will be randomly assigned into one of two groups, either the Treatment Group which receive IV acetaminophen or the Usual Care Group which will receive intravenous morphine or hydromorphone as needed for pain control. A Nasogastric (NG) tube will be placed when it is indicated, if patient is having significant nausea or vomiting. Pain scores will be followed as usual pain management assessment and reported in the medical record. Once SBO is resolved (usually 3 days after admission), active study participation will end. Participants may be followed via their medical record up to 30 days after discharge.
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
- Single (Participant)
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
- •Small bowel obstruction diagnosed by radiographic study; and
- •Abdominal pain on admission.
- •Nothing per mouth diet.
- •The ability to give appropriate consent or have an appropriate representative available to do so.
排除标准
- •Known liver failure or cirrhosis.
- •Acetaminophen toxicity on admission.
- •Known acetaminophen allergy.
- •Alcohol intoxication on admission.
- •History of substance abuse.
- •Creatinine clearance < 30 (or Creatinine level > 2).
- •Liver transplant recipients.
- •Ileus on admission.
- •Admitted for surgical intervention for SBO.
- •Admitted for venting Gastric tube placement.
- •On chronic opioid therapy (defined as use of opioid on daily or near daily basis within previous 45 days (both long acting and short acting).
- •Presentation without abdominal pain on admission.
- •Already hospitalized for other reasons and develop SBO while at the hospital.
- •Pregnant women.
- •Unable to provide informed consent.
研究组 & 干预措施
IV Acetaminophen Group
Subjects presented to emergency department (ED) and diagnosed with small bowel obstruction which receive IV acetaminophen
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Resolution of small bowel obstruction
时间窗: 3 days
Days until small bowel obstruction resolution, measured by admission date to date that diet was placed
Pain Scores
时间窗: 3 days
Pain is measured by a pain scale of subjective pain reported by patients and measured by nurses and ranges from 0 (no pain) to 10 (worst pain).
Length of hospital stay
时间窗: 3 days
Measured by days from admission day to discharge day
次要结局
- Death(3 days)
- Bowel Perforation(3 days)
- Surgery(3 days)
- Allergic reaction to acetaminophen(3 days)
研究者
Tatjana Gavrancic
Principal Investigator
Mayo Clinic