TerminatedNCT04816877PCA-APUpdated Nov 22, 2024Results posted

Use of Patient-Controlled Analgesia in Acute Pancreatitis

An observational study in Acute Pancreatitis, sponsored by Beth Israel Deaconess Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-11-22.

Sponsored by Beth Israel Deaconess Medical Center · Observational

Why this study was terminated

inadequate recruitment despite efforts

Study type: Observational
Model: Case-control
Time perspective: Prospective
Enrollment: 7
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Read the detailed description

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:
Acute onset of persistent, severe, epigastric pain often radiating to the back,
Elevation in serum lipase or amylase to three times or greater than the upper limit of normal,
Characteristic findings of acute pancreatitis on imaging (contrast-enhanced computed tomography [CT], magnetic resonance imaging [MRI], or transabdominal ultrasonography).
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.
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.
The initial protocol for analgesic administration in each arm is as follows:
- Recommended algorithm for physician directed analgesia (PDA) arm:
  - IV Hydromorphone 0.4 mg every 4 hours PRN for pain 4-6
  - IV hydromorphone 0.6 mg every 2 hours PRN for pain 7-10
  - 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)
  - Maximum opioid dosing: 1 mg per hour and 3 mg of IV hydromorphone per 4 hours
  - 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
- Recommended algorithm for patient controlled analgesia (PCA) arm:
  - IV Hydromorphone 0.1 mg every 10 minutes
  - 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)
  - Maximum opioid dosing: 1 mg per hour and 3 mg of IV hydromorphone per 4 hours
  - 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
- Recommended for all patients:
  - PO Acetaminophen 1000 mg every 8 hours scheduled
  - IV Naloxone 40-80 mcg PRN for respiratory depression (RR\<10) or significant somnolence
  - PO Benadryl 25mg every 4 hours PRN moderate to severe pruritis
- Recommended algorithm for transition to oral:
  - PO Oxycodone 5mg every 4 hours PRN for pain 4-6
  - PO Oxycodone 10mg every 4 hours PRN for pain 7-10
  - Rescue PO Oxycodone 5mg 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 PO oxycodone (breakthrough pain)
Dosing and frequencies of medications in the above algorithms are recommendations. The recommended doses are not required for maintenance in the study and we anticipate that they may change given patient characteristics and variable response to medication, the rapidly evolving nature of acute pancreatitis, and hospitalist preferences. However, the mode of IV opioid administration (PDA vs PCA) should remain as assigned until transition to PO opioid.
Each patient will be closely monitored for adverse events related to opioid administration to include cardiorespiratory decompensation, hemodynamic instability, nausea, vomiting, confusion, altered mental status, headache, drowsiness, etc. This monitoring will include continuous pulse oximetry in addition to vital sign measurement every 4 hours.
The efficacy of each treatment arm to adequately control the patient's pain will be assessed with scheduled use of the Numeric Rating Scale (NRS) every 4 hours by the nursing staff. Pain rating on the NRS will be documented by the nursing staff after each assessment. In an NRS, patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas 10 represents 'the worst pain ever possible'.
Likert scale of 1 to 10 (1 = Very poor, 10= excellent) will be used to grade overall patient satisfaction with pain control.
Once each patient's pain is well controlled on IV opioid administration (as determined by the attending physician) and they can tolerate intake by mouth, transition from IV to PO opioid medication can be made in each arm by the attending physician. If the patient is unable to tolerate either the PDA or the PCA arm for any reason and requires switching over to the other arm as part of his/her clinical care, they will be withdrawn from the study and their data will be excluded while analyzing the results. AP has a variable course and may require IV opioids after transition to PO opioids. The modality of IV opioid administration will revert to the assigned treatment arm.
Other aspects of each patient's routine clinical care will continue as per the attending physician under whom the patient is admitted regardless of treatment arm status (PDA vs PCA).
At the end of their hospital stay, investigators will document study outcomes.
Investigators expect to enroll patients over a 36-month period from the start date of the study. Based on this, investigators expect patient enrollment to end by 4/30/2024. Investigators will plan to perform data analysis at two points: 1. Interim data analysis at a predetermined point in the study (mid-point of study), and 2. At the end of the study once patient enrollment has been completed.

Conditions studied

Acute Pancreatitis

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Pancreatitis 759

In context

Pancreatitis

759 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.

This study's enrollment of 7 is below the median of 179 across 282 observational studies indexed under Pancreatitis.

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Lead sponsor

Beth Israel Deaconess Medical Center is the lead sponsor of 565 studies on the registry; 81 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 62 (83%) have results posted.

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Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Observational model: Case-control
Time perspective: Prospective
Enrollment: 7 participants (actual)
Patient registry: No

Groups and cohorts

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

DrugOpioid
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.

What researchers measure

Primary outcomes

Length of Stay (Days)
amount of time enrolled participants are admitted to the hospital.
Time frame: 4-21 days

Secondary outcomes

Number of Days the Patient Gets Nothing by Mouth (NPO) Before Diet is Initiated
The duration of time between patient presentation and dietary advancement was noted.
Time frame: 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
Mean pain scores over the first 24 hours, second 24 hours, and course of their hospital stay were recorded using a numeric rating scale which ranged from 0 to 10 where 0 is no pain and 10 is the worst pain imaginable.
Time frame: Day 1 of hospitalization and Average Pain Score throughout entire hospital stay, assessed up to 12 days
Total Morphine Milligram Equivalent
The total opioid dose for pain control was quantified through Total morphine milligram equivalent which was calculated based on the standardized conversion of opioids.
Time frame: Through hospital stay, an average of 5-7 days
Time to Transition to PO Opioids
The time from the transition of IV opioids to PO opioids was recorded.
Time frame: Through hospital stay, an average of 5-7 days
Number of Participants With Opioid-related Adverse Events
Opioid-related adverse events were prospectively collected.
Time frame: Through hospital stay, an average of 5-7 days
Number of Participants With Use of Naloxone and Antiemetics
Use of naloxone and antiemetics was noted for each recruited subject.
Time frame: Through hospital stay, an average of 5-7 days
Number of Participants With ICU Transfer
Transfer of patients to the intensive care unit was prospectively noted.
Time frame: Through hospital stay, an average of 5-7 days
Number of Participants With 30-day Readmission
The 30-day readmission rates were prospectively noted.
Time frame: 30 days
All-cause Inpatient Mortality and Opioid-related Inpatient Mortality
All-cause inpatient mortality and opioid-related inpatient mortality were recorded.
Time frame: Through hospital stay, an average of 5-7 days
30-day Mortality
30-day mortality was prospectively noted.
Time frame: 30 days
Daily Morphine Milliequivalents on Discharge
Daily morphine milliequivalents on discharge were recorded prospectively
Time frame: Through hospital stay, an average of 5-7 days

Results

Posted Nov 22, 2024

Limitations and caveats

Early termination leading to small numbers of subjects analyzed

Participant flow

The participants were recruited from a single tertiary care center. The first patient was recruited on 2/22/2022 and the last patient on 10/17/2023.

Participant flow — Overall Study
Milestone	Patient Controlled Analgesia (PCA) Group	Physician Directed Analgesia (PDA) Group
Started	3	4
Completed	2	4
Not completed	1	0
Withdrew: Withdrawal by subject	1	0

Outcome measures

PrimaryLength of Stay (Days)

amount of time enrolled participants are admitted to the hospital.

Time frame:: 4-21 days
Reported as:: Mean · days

Length of Stay (Days)
days	Patient Controlled Analgesia (PCA) Group	Physician Directed Analgesia (PDA) Group
Length of Stay (Days)	12 ± 4	9.75 ± 5.5

SecondaryNumber of Days the Patient Gets Nothing by Mouth (NPO) Before Diet is Initiated

The duration of time between patient presentation and dietary advancement was noted.

Time frame:: From date of hospital admission to discharge, assessed up to 12 days
Reported as:: Mean · days

Number of Days the Patient Gets Nothing by Mouth (NPO) Before Diet is Initiated
days	Patient Controlled Analgesia (PCA) Group	Physician Directed Analgesia (PDA) Group
Number of Days the Patient Gets Nothing by Mouth (NPO) Before Diet is Initiated	3 ± 0	6.25 ± 7.8

SecondaryMean Pain Scores on a Numeric Rating Scale (NRS) Over the First 24 Hours and Over Entire Course of Their Hospital Stay

Mean pain scores over the first 24 hours, second 24 hours, and course of their hospital stay were recorded using a numeric rating scale which ranged from 0 to 10 where 0 is no pain and 10 is the worst pain imaginable.

Time frame:: Day 1 of hospitalization and Average Pain Score throughout entire hospital stay, assessed up to 12 days
Reported as:: Mean · units on a scale

Mean Pain Scores on a Numeric Rating Scale (NRS) Over the First 24 Hours and Over Entire Course of Their Hospital Stay
units on a scale	Patient Controlled Analgesia (PCA) Group	Physician Directed Analgesia (PDA) Group
Mean NRS over 24 hrs	5.5 ± 0	5.6 ± 3.14
NRS over entire stay	2.1 ± 0	7 ± 3.46

SecondaryTotal Morphine Milligram Equivalent

The total opioid dose for pain control was quantified through Total morphine milligram equivalent which was calculated based on the standardized conversion of opioids.

Time frame:: Through hospital stay, an average of 5-7 days
Reported as:: Mean · morphine milligram equivalents

Total Morphine Milligram Equivalent
morphine milligram equivalents	Patient Controlled Analgesia (PCA) Group	Physician Directed Analgesia (PDA) Group
Total Morphine Milligram Equivalent	110 ± 0	291 ± 324.8

SecondaryTime to Transition to PO Opioids

The time from the transition of IV opioids to PO opioids was recorded.

Time frame:: Through hospital stay, an average of 5-7 days
Reported as:: Mean · days

Time to Transition to PO Opioids
days	Patient Controlled Analgesia (PCA) Group	Physician Directed Analgesia (PDA) Group
Time to Transition to PO Opioids	2 ± 0	7.67 ± 8.9

SecondaryNumber of Participants With Opioid-related Adverse Events

Opioid-related adverse events were prospectively collected.

Time frame:: Through hospital stay, an average of 5-7 days
Reported as:: Count of participants · Participants

Number of Participants With Opioid-related Adverse Events
Participants	Physician Directed Analgesia (PDA) Group	Patient Controlled Analgesia (PCA) Group
Number of Participants With Opioid-related Adverse Events	0	0

SecondaryNumber of Participants With Use of Naloxone and Antiemetics

Use of naloxone and antiemetics was noted for each recruited subject.

Time frame:: Through hospital stay, an average of 5-7 days
Reported as:: Count of participants · Participants

Number of Participants With Use of Naloxone and Antiemetics
Participants	Patient Controlled Analgesia (PCA) Group	Physician Directed Analgesia (PDA) Group
Number of Participants With Use of Naloxone and Antiemetics	0	0

SecondaryNumber of Participants With ICU Transfer

Transfer of patients to the intensive care unit was prospectively noted.

Time frame:: Through hospital stay, an average of 5-7 days
Reported as:: Count of participants · Participants

Number of Participants With ICU Transfer
Participants	Patient Controlled Analgesia (PCA) Group	Physician Directed Analgesia (PDA) Group
Number of Participants With ICU Transfer	0	0

SecondaryNumber of Participants With 30-day Readmission

The 30-day readmission rates were prospectively noted.

Time frame:: 30 days
Reported as:: Count of participants · Participants

Number of Participants With 30-day Readmission
Participants	Patient Controlled Analgesia (PCA) Group	Physician Directed Analgesia (PDA) Group
Number of Participants With 30-day Readmission	1	0

SecondaryAll-cause Inpatient Mortality and Opioid-related Inpatient Mortality

All-cause inpatient mortality and opioid-related inpatient mortality were recorded.

Time frame:: Through hospital stay, an average of 5-7 days
Reported as:: Count of participants · Participants

All-cause Inpatient Mortality and Opioid-related Inpatient Mortality
Participants	Patient Controlled Analgesia (PCA) Group	Physician Directed Analgesia (PDA) Group
All-cause Inpatient Mortality and Opioid-related Inpatient Mortality	0	0

Secondary30-day Mortality

30-day mortality was prospectively noted.

Time frame:: 30 days
Reported as:: Count of participants · Participants

30-day Mortality
Participants	Physician Directed Analgesia (PDA) Group	Patient Controlled Analgesia (PCA) Group
30-day Mortality	0	0

SecondaryDaily Morphine Milliequivalents on Discharge

Daily morphine milliequivalents on discharge were recorded prospectively

Time frame:: Through hospital stay, an average of 5-7 days
Reported as:: Mean · morphine milligram equivalents

Daily Morphine Milliequivalents on Discharge
morphine milligram equivalents	Patient Controlled Analgesia (PCA) Group	Physician Directed Analgesia (PDA) Group
Daily Morphine Milliequivalents on Discharge	15 ± 25.8	11.25 ± 22.5

Adverse events

Collected over 1 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Patient Controlled Analgesia (PCA) Group	0/3 (0%)	0/3 (0%)	0/3 (0%)
Physician Directed Analgesia (PDA) Group	0/4 (0%)	0/4 (0%)	0/4 (0%)

Baseline characteristics

We anticipated a non-parametric distribution of age which warranted description as median (IQR). Sex and ethnoracial distribution were described as frequency (percentage).

Age, Continuous
Age, Continuous(years)	Physician Directed Analgesia (PDA) Group	Patient Controlled Analgesia (PCA) Group	Total
Median	60 (54 to 67.25)	58 (58 to 59)	58 (56.5 to 62.5)

Sex: Female, Male
Sex: Female, Male(Participants)	Physician Directed Analgesia (PDA) Group	Patient Controlled Analgesia (PCA) Group	Total
Female	3	2	5
Male	1	1	2

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Physician Directed Analgesia (PDA) Group	Patient Controlled Analgesia (PCA) Group	Total
Hispanic or Latino	1	0	1
Not Hispanic or Latino	3	3	6
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Physician Directed Analgesia (PDA) Group	Patient Controlled Analgesia (PCA) Group	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	0	0
White	3	3	6
More than one race	0	0	0
Unknown or Not Reported	1	0	1

Region of Enrollment
Region of Enrollment(participants)	Physician Directed Analgesia (PDA) Group	Patient Controlled Analgesia (PCA) Group	Total
United States	4	3	7

Study locations

1 site

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215, United States

References and documents

Study documents

Protocol and statistical analysis plan · Mar 2, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04816877
Lead sponsor: Beth Israel Deaconess Medical Center
Responsible party: Sunil Sheth (Associate Professor of Medicine, Beth Israel Deaconess Medical Center) — Principal investigator
First posted: Mar 25, 2021
Start date: Feb 22, 2022
Primary completion: Dec 7, 2023
Completion: Dec 7, 2023
Results posted: Nov 22, 2024
Last update: Nov 22, 2024

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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