Use Of Patient Controlled Analgesia For Treating The Pain Of Acute Pancreatitis: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Length of Stay (Days)
研究概览
简要总结
Acute pancreatitis (AP) represents a critical health concern nationwide, with estimated 274,000 admissions annually and at a cost of 2.6 billion dollars. Current treatment strategies for AP are limited to supportive care with fluid resuscitation, analgesia, nutrition and prevention of end organ damage. Abdominal pain is often the predominant symptom in patients with AP and is treated with analgesics. As there is currently no disease-specific medical treatment to change the natural history of pancreatitis, pain control remains central to the treatment of AP. Among the analgesics, opioids have been shown to be provide safe and effective pain control in patients with AP. Current literature shows that there is no difference in the risk of pancreatitis complications or clinically serious adverse events between opioids and other analgesia options. Among hospitalized AP patients, adequate pain control often requires the use of intravenous (IV) opiates in the first 24-48 hours, which can later be transitioned to oral (PO) opioids. While there are various methods of delivering opioid medications such as IV, PO, and transdermal to name a few, IV opioids are commonly administered, either on a scheduled and/or on an as needed (PRN) basis as directed by the attending physician. In contrast to the conventional, method of physician directed IV opioid delivery, patient-controlled analgesia (PCA) is a form of IV opioid medication delivery in which the patient can rapidly titrate the opioid dose to manage variable levels of pain. This modality of opioid administration is often preferred by patients and has been widely used in postsurgical and obstetric patients to effectively treat their pain. PCA allows for faster intervention on pain limiting time to treatment and peak pain levels and has also been shown to decrease total opioid dose. However, there is limited evidence in published literature assessing the feasibility of using PCA to treat the pain of AP or comparing its efficacy and safety profile compared to the more traditional physician directed analgesia. One retrospective study has shown that use of PCA was surprisingly associated with longer hospital stays and higher rates of outpatient opioid use when compared to routine physician-directed analgesia (PDA), however there are no prospective trials to study this comparison. Hence, in this study, the investigators will compare the effects of using PCA among patients with AP to that of conventional PDA.
详细描述
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Investigators will identify patients with AP based on the 2012 revised Atlanta criteria for diagnosis, i.e., AP is diagnosed if 2 out of the following 3 criteria are met:
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Acute onset of persistent, severe, epigastric pain often radiating to the back,
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Elevation in serum lipase or amylase to three times or greater than the upper limit of normal,
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Characteristic findings of acute pancreatitis on imaging (contrast-enhanced computed tomography [CT], magnetic resonance imaging [MRI], or transabdominal ultrasonography).
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Patients will be recruited for participation in this study while they are hospitalized with AP at Beth Israel Deaconess Medical Center. Once the patient has been transferred from the emergency department to the hospital floor, we will identify and recruit them for participation in our study.
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After obtaining informed consent from the patient, the patient will be enrolled by simple randomization to either the PCA or the PDA arm of the study. The research staff will assign patients to either the PCA arm or the PDA arm based on a standard randomization. Once, a patient has consented, the research staff will assign them to the next sequential study identidication number and corresponding study arm and let the attending hospitalist know of the result. The patient will then be enrolled in their assigned arm.
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The initial protocol for analgesic administration in each arm is as follows:
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Recommended algorithm for physician directed analgesia (PDA) arm:
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IV Hydromorphone 0.4 mg every 4 hours PRN for pain 4-6
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IV hydromorphone 0.6 mg every 2 hours PRN for pain 7-10
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Rescue IV hydromorphone 0.4 mg every 2 hours PRN for pain 4-10 = only to be given as a 'rescue dose' if patient has persistent pain despite using every 4 hours PRN IV hydromorphone (breakthrough pain)
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Maximum opioid dosing: 1 mg per hour and 3 mg of IV hydromorphone per 4 hours
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If patient has received more than 2 rescue doses for breakthrough pain in 12 hours or is in uncontrolled pain: Hospitalist's recommended step-up orders: IV hydromorphone 0.8 mg every 4 hours PRN 4-6
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Recommended algorithm for patient controlled analgesia (PCA) arm:
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IV Hydromorphone 0.1 mg every 10 minutes
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Rescue IV hydromorphone 0.4 mg every 2 houra PRN for pain 4-6, hydromorphone 0.6 mg every 2 hours PRN for pain 7-10 = only to be given as a 'rescue' dose for if patient has persistent pain despite using PCA (breakthrough pain)
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Maximum opioid dosing: 1 mg per hour and 3 mg of IV hydromorphone per 4 hours
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If patient has received more than 2 rescue doses for breakthrough pain in 12 hours or is in uncontrolled pain: Hospitalist's recommended step-up orders: IV hydromorphone 0.2 mg every 10 minutes
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Recommended for all patients:
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PO Acetaminophen 1000 mg every 8 hours scheduled
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IV Naloxone 40-80 mcg PRN for respiratory depression (RR<10) or significant somnolence
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PO Benadryl 25mg every 4 hours PRN moderate to severe pruritis
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Recommended algorithm for transition to oral:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of acute pancreatitis confirmed by revised Atlanta criteria
- •Admitted to the medical floor within 48 hours of emergency department arrival at Beth Israel Deaconess Medical Center (BIDMC) in Boston, Massachusetts.
- •Age 18-65
排除标准
- •Active illicit drug use
- •Discharged from the emergency department
- •Direct admission to ICU from emergency department
- •Known allergy to opioid medications
- •Age <18 or >65
- •Known chronic pain syndrome or concurrent other medical condition with chronic pain
- •Active encephalopathy/confusion/delirium/psychiatric illness or any other condition that limits capacity
- •Known chronic opioid use
- •Renal insufficiency (baseline Creatinine of >2 and/or acute kidney injury with Creatinine>3 on admission)
- •Known allergy to acetaminophen or hepatic dysfunction otherwise limiting acetaminophen use
研究组 & 干预措施
Patient controlled analgesia (PCA) group
Patients in this group will be allocated to the PCA arm, i.e., they will be receiving a PCA pump for administration of opioids.
干预措施: Opioid (Drug)
Physician directed analgesia (PDA) group
Patients in this group will be allocated to the PDA arm, i.e., they will be receiving opioids administered by the nurse, as and when directed by the physician.
干预措施: Opioid (Drug)
结局指标
主要结局
Length of Stay (Days)
时间窗: 4-21 days
amount of time enrolled participants are admitted to the hospital.
次要结局
- Number of Days the Patient Gets Nothing by Mouth (NPO) Before Diet is Initiated(From date of hospital admission to discharge, assessed up to 12 days)
- Mean Pain Scores on a Numeric Rating Scale (NRS) Over the First 24 Hours and Over Entire Course of Their Hospital Stay(Day 1 of hospitalization and Average Pain Score throughout entire hospital stay, assessed up to 12 days)
- Total Morphine Milligram Equivalent(Through hospital stay, an average of 5-7 days)
- Time to Transition to PO Opioids(Through hospital stay, an average of 5-7 days)
- Number of Participants With Opioid-related Adverse Events(Through hospital stay, an average of 5-7 days)
- Number of Participants With Use of Naloxone and Antiemetics(Through hospital stay, an average of 5-7 days)
- Number of Participants With ICU Transfer(Through hospital stay, an average of 5-7 days)
- Number of Participants With 30-day Readmission(30 days)
- All-cause Inpatient Mortality and Opioid-related Inpatient Mortality(Through hospital stay, an average of 5-7 days)
- 30-day Mortality(30 days)
- Daily Morphine Milliequivalents on Discharge(Through hospital stay, an average of 5-7 days)
研究者
Sunil Sheth
Associate Professor of Medicine
Beth Israel Deaconess Medical Center