Patient Controlled Self-Administration of Oral Liquid Medication: Acetaminophen Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Participant enrollment rate
研究概览
简要总结
This is a proof of concept pilot study investigating the feasibility and acceptability of patient controlled oral medication administration, using the commonly used and low risk medication in the hospital, oral acetaminophen.
详细描述
The primary objective of this prospective pilot study is to determine the feasibility of patient-controlled administration of liquid oral acetaminophen using recruitment rate and adherence to the study protocol rate as surrogate markers. Investigators hypothesize that patients will accept the new concept of self-controlled oral administration of liquid acetaminophen, with more than 50% patient enrollment rate and less than 20% withdrawal rate from the study group to the traditional nurse-administered acetaminophen pills.
The secondary objective of this study is to determine the preliminary efficacy of patient-controlled delivery of oral acetaminophen administration.
If the medication is spilled or otherwise not dispensed correctly, the patients will be instructed to report this instantly to the nurse. The nurse will document and provide a replacement.
All study participants have the option to call the nurse for assistance with break through pain. In addition, there is a call button to call for help with any other needs or discomfort.
All other medications, such as NSAIDs or oral opioids, will be administered as prescribed.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants
- •Adult patients older than 18 years old admitted to SRC for total shoulder and reverse total shoulder arthroplasty
- •The nurse who will administer acetaminophen to a study patient.
排除标准
- •Participants
- •Pregnant patient
- •Patients that cannot swallow pills or cannot take liquid (for example due to risk of aspiration)
- •Emergency surgery
- •Chronic pain
- •On home opioids, any other pain modulating medications including benzodiazepine, Neurontin, ketamine.
- •Past medical or social history of substance abuse disorder, including ethanol misuse disorder, marijuana misuse disorder
- •History of any psychiatric disorders including anxiety, depression, any cognitive dysfunction
- •Any patients who cannot provide informed consents on their own (those who would need Legally Authorized Representatives (LARs) or surrogates)
- •Liver dysfunction limiting amount of safe oral acetaminophen
- •baseline hyperbilirubinemia (ex: chronic liver disease, Gilbert's)
- •patients unable to take PO
- •Patients with neurologic, neuromuscular, or movement disorders unable to drink from a cup.
- •any nurse who is not involved in the direct care of a study patient, or who is not comfortable with setting up the PCA pump.
研究组 & 干预措施
Nurse Administered Acetaminophen
Participants will receive acetaminophen pills 650 mg every 4 hours as needed (PRN) administered by nurse per standard of care
干预措施: Acetaminophen 650 mg Oral Tablet (Drug)
CADD pump Administered Acetaminophen (Participant Controlled)
Participants will receive a CADD pump primed and programmed to deliver 650 mg liquid acetaminophen into a medication cup every 4 hours as needed (PRN).
干预措施: Acetaminophen 650mg Liquid (Drug)
CADD pump Administered Acetaminophen (Participant Controlled)
Participants will receive a CADD pump primed and programmed to deliver 650 mg liquid acetaminophen into a medication cup every 4 hours as needed (PRN).
干预措施: CADD pump (Device)
结局指标
主要结局
Participant enrollment rate
时间窗: up to 12 months
The percentage of participants that enroll
Participant adherence to the study protocol
时间窗: up to 12 months
Percentage of participants that withdraw from treatment group, i.e. switch from patient controlled liquid group to the nurse-administered pill control group
Nurse Questionnaire
时间窗: Study day 0, 1, 2 and 3
Nurse ranking of patient controlled liquid oral acetaminophen vs. nurse-administered pill acetaminophen. (Mean score, Total Scale of 0-10: 0: much worse; 5:same; 10: much better)
次要结局
- Mean daily acetaminophen consumption(12 months)
- Mean Pain score(12 months)
- Mean time to medication delivery(12 months)