Acute PancreatitisPCA-APNCT04816877
Use of Patient-Controlled Analgesia in Acute Pancreatitis
An observational study of Acute Pancreatitis, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- Opioid
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2022to 7 Dec 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Use Of Patient Controlled Analgesia For Treating The Pain Of Acute Pancreatitis: A Prospective Study
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
- Acute Pancreatitis
- Being tested
- Opioid
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OpioidDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Opioid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay (Days)
amount of time enrolled participants are admitted to the hospital.
Measured: 4-21 days
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through hospital stay, an average of 5-7 days
Number of Participants With Opioid-related Adverse Events
Opioid-related adverse events were prospectively collected.
Measured: 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.
Measured: 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.
Measured: Through hospital stay, an average of 5-7 days
Number of Participants With 30-day Readmission
The 30-day readmission rates were prospectively noted.
Measured: 30 days
All-cause Inpatient Mortality and Opioid-related Inpatient Mortality
All-cause inpatient mortality and opioid-related inpatient mortality were recorded.
Measured: Through hospital stay, an average of 5-7 days
30-day Mortality
30-day mortality was prospectively noted.
Measured: 30 days
Daily Morphine Milliequivalents on Discharge
Daily morphine milliequivalents on discharge were recorded prospectively
Measured: Through hospital stay, an average of 5-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start22 Feb 2022
- Primary completion7 Dec 2023
- Study completion7 Dec 2023
Why it stopped: inadequate recruitment despite efforts
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunil Sheth, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816877
- Sponsor's protocol ID
- 2021P000203
- Acronym
- PCA-AP
- Status last verified
- Sep 2024
- First submitted
- 21 Mar 2021
- Last updated
- 22 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use Of Patient Controlled Analgesia For Treating The Pain Of Acute Pancreatitis: A Prospective Study
- ClinicalTrials.gov ID
- NCT04816877
- Acronym / sponsor ID
- PCA-AP / 2021P000203
- Conditions
- Acute Pancreatitis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: inadequate recruitment despite efforts
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 7 Dec 2023 (actual)
- Study completion
- 7 Dec 2023 (actual)
- First posted
- 25 Mar 2021 (actual)
- Results
- Posted 22 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient controlled analgesia (PCA) group | – | Drug: OpioidPatients in this group will be allocated to the PCA arm, i.e., they will be receiving a PCA pump for administration of opioids. |
| Physician directed analgesia (PDA) group | – | Drug: OpioidPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OpioidPatients 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. | Drug | Patient controlled analgesia (PCA) group, Physician directed analgesia (PDA) group |
Primary outcome
Length of Stay (Days)
Time frame: 4-21 days
amount of time enrolled participants are admitted to the hospital.
11 secondary outcomes
Number of Days the Patient Gets Nothing by Mouth (NPO) Before Diet is Initiated
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
Time frame: Day 1 of hospitalization and Average Pain Score throughout entire hospital stay, assessed up to 12 days
Total Morphine Milligram Equivalent
Time frame: Through hospital stay, an average of 5-7 days
Time to Transition to PO Opioids
Time frame: Through hospital stay, an average of 5-7 days
Number of Participants With Opioid-related Adverse Events
Time frame: Through hospital stay, an average of 5-7 days
Number of Participants With Use of Naloxone and Antiemetics
Time frame: Through hospital stay, an average of 5-7 days
Number of Participants With ICU Transfer
Time frame: Through hospital stay, an average of 5-7 days
Number of Participants With 30-day Readmission
Time frame: 30 days
All-cause Inpatient Mortality and Opioid-related Inpatient Mortality
Time frame: Through hospital stay, an average of 5-7 days
30-day Mortality
Time frame: 30 days
Daily Morphine Milliequivalents on Discharge
Time frame: Through hospital stay, an average of 5-7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Stay (Days) (time frame: 4-21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.