Use of Patient-Controlled Analgesia in Acute Pancreatitis

NCT04816877 | Terminated Results FDA Drug

• 1 other identifier: 2021P000203
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Length of Stay (Days)

  amount of time enrolled participants are admitted to the hospital.

  4-21 days

Secondary Outcomes (11)

• 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

Study Arms (2)

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.

Drug: Opioid

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.

Drug: Opioid

Interventions

Opioid DRUG

Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.

Patient controlled analgesia (PCA) group; Physician directed analgesia (PDA) group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with acute pancreatitis who are admitted to our hospital (BIDMC) and meet above mentioned inclusion criteria will be enrolled in the study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Pancreatitis

Interventions

Analgesics, Opioid

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Dr. Sunil Sheth
• Organization: Beth Israel Deaconess Medical Center

ssheth@bidmc.harvard.edu

6176675576

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: March 21, 2021
• First Posted: March 25, 2021
• Study Start: February 22, 2022
• Primary Completion: December 7, 2023
• Study Completion: December 7, 2023
• Last Updated: November 22, 2024
• Results First Posted: November 22, 2024

Record last verified: 2024-09

Locations

US (1)