Evaluation of the Patient-Controlled Dispenser & Deactivator (PCDD) Generation 1 System for Oral Liquid Acetaminophen Delivery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Participant enrollment rate
研究概览
简要总结
This prospective randomized pilot study evaluates the feasibility, acceptability, and preliminary efficacy of the Patient-Controlled Dispenser and Deactivator (PCDD) Generation 1 system for patient-controlled oral liquid acetaminophen administration in postoperative total shoulder replacement inpatients compared with standard nurse-administered oral acetaminophen delivery.
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 the Patient-Controlled Dispenser and Deactivator (PCDD) system, using recruitment rate and cross-over rates as surrogate markers.
The secondary objective of this study is to determine the preliminary efficacy of patient-controlled delivery of oral acetaminophen administration using the PCDD system.
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
- •Admitted to the participating orthopedic service for elective total shoulder replacement
- •Received a preoperative brachial plexus block
- •English speaking - as on-site study members are only fluent in English
- •Able to independently use the PCDD system and follow basic operating instructions
- •Registered nurse employed at Yale New Haven Hospital.
- •Provides clinical care to an enrolled study participant during the participant's hospitalization.
- •Willing and able to provide informed consent.
排除标准
- •Participants
- •Patient refusal to participate
- •Pregnancy: all child bearing age patients will receive a urine screening test on the day of surgery and this result will be documented in the EMR epic. This is an elective procedure and the surgery will almost always be cancelled in the case of positive pregnancy test. In the extremely rare event the care proceeds, we will exclude the patient from the study. Emergency surgery
- •Cognitive impairment preventing informed consent or independent use of the device
- •Chronic pain requiring ongoing pain management or home opioid use
- •Substance use disorder
- •Failed preoperative brachial plexus block, defined as significant postoperative pain in the PACU requiring early escalation of analgesic management
- •Declines or is unwilling to provide informed consent.
研究组 & 干预措施
Acetaminophen delivery using the PCDD system
Patient-controlled oral liquid acetaminophen delivery using the PCDD system in postoperative total shoulder replacement while inpatient.
干预措施: PCDD Generation 1 system (Device)
Standard nurse-administered acetaminophen
Participants will receive standard nurse-administered as-needed acetaminophen pills in postoperative total shoulder replacement while inpatient.
结局指标
主要结局
Participant enrollment rate
时间窗: 1-7 days prior to surgery
Percent participants enrolled out of all screened
Retention in assigned treatment group
时间窗: From enrollment to discharge, up to 3 days
Percentage of participants who remain in their assigned treatment group for the duration of study participation.
Mean score Patient Questionnaire
时间窗: Baseline up to Day 3
Patient satisfaction with PCDD system. Total score range 0-10 with higher scores indicating more satisfaction.
Mean score Nurse Questionnaire
时间窗: Baseline up to Day 3
Nurse satisfaction with PCDD system. Total score range 0-10 with higher scores indicating more satisfaction.
次要结局
- Mean Acetaminophen consumption(From anesthesia end time to discharge time, up to 48 hours)
- Mean Opioid consumption(From anesthesia end time to discharge time, up to 48 hours)
- Mean Pain scores(From anesthesia end time to discharge time, up to 48 hours)
- Mean Time to first opioid request(From anesthesia end time to discharge time, up to 48 hours)
- Mean time to medication delivery(From anesthesia end time to discharge time, up to 48 hours)
- Mean awake time to assess sleep disruption related to pain control(From anesthesia end time to discharge time, up to 48 hours)
- Mean number of pain-related nursing calls(From anesthesia end time to discharge time, up to 48 hours)