Acute PancreatitisPhase 4NCT04282200
Ketorolac in Acute Pancreatitis
A Phase 4 study testing Ketorolac in people with Acute Pancreatitis, run by University of Cincinnati at 1 site in United States.
Trial summary
This study will compare pain management strategies for patients hospitalized with acute pancreatitis. Standard of care pain management will be compared to standard of care plus intravenous ketorolac. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- Ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2020to Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old
- opioid order for pain secondary to acute pancreatitis
- diagnosis of acute pancreatitis defined by the presence of two of the following three criteria: abdominal pain, lipase > 3x upper limit of normal, and/or findings of AP on imaging
- a patient with acute-on-chronic pancreatitis that does not exhibit elevated lipase levels is eligible for inclusion if the patient has the other two criteria
- received at least 3 L of IV crystalloid fluid within first 24 hours of admission to ensure patients have received initial volume expansion
- hemodynamically stable represented by a mean arterial blood pressure (MAP) of ≥65 mmHg
- female patients not documented in chart as post-menopause must have a negative pregnancy test
Who cannot join
- history of chronic heart failure
- history of acute coronary syndrome (ST-elevation myocardial infarction (STEMI) or non-ST elevation myocardial infarction (NSTEMI)) within last 6 months
- history of ischemic or hemorrhagic stroke within last 6 months
- history of upper gastrointestinal bleed (GI) within last 6 months
- history of inflammatory bowel disease
- history of cirrhosis
Show all 15Show fewer
- any overt, active bleeding requiring blood transfusion
- considered to be high bleed risk (platelet < 50,000/mcL)
- pregnant or breastfeeding
- prisoners
- cognitively impaired patients: not alert and oriented to person, place, and time (patient must be able to consent)
- allergy to NSAIDs, ketorolac, or aspirin
- admission to an intensive care unit
- evidence of infected pancreatitis (i.e. abscess) on imaging studies
- acute kidney injury or chronic kidney disease with CrCl<30
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
About this study
Official title: The Use of Intravenous Ketorolac in a Multimodal Approach to Pain Management in Acute Pancreatitis
This study will compare pain management strategies for patients hospitalized with acute pancreatitis. Standard of care pain management will be compared to standard of care plus intravenous ketorolac.
Read the detailed description
Patients hospitalized for acute pancreatitis and admitted to an internal medicine team will be eligible for study. Patients enrolled will be blindly randomized to receive open-label pain management of standard of care or standard of care plus intravenous ketorolac. Patients will be enrolled between hour 24 and 48 of hospitalization.
- Conditions
- Acute Pancreatitis
- Being tested
- Ketorolac
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
intravenous ketorolac 30 mg every 6 hours
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Patients receiving standard of care pain management including opioids. |
| Ketorolac | Active comparator | Patients will receive standard of care pain management plus intravenous ketorolac. Receives: Drug: Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid use during study enrollment
oral morphine equivalents (OME)
Measured: day 1 to day 5 of study
Secondary outcomes (2)
Day-to-day oral morphine equivalents
Compare opioid use in each day of study
Measured: day 1 to day 5 of study
Duration of intravenous opioid use
compare duration of need for IV opioids and transition to oral opioids
Measured: During hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start24 Feb 2020
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Gentene, University of Cincinnati
- Investigators
- Anthony J Gentene, PharmD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282200
- Sponsor's protocol ID
- 2019-0283
- Status last verified
- Dec 2020
- First submitted
- 18 Feb 2020
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Intravenous Ketorolac in a Multimodal Approach to Pain Management in Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT04282200
- Acronym / sponsor ID
- 2019-0283
- Conditions
- Acute Pancreatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare pain management strategies for patients hospitalized with acute pancreatitis. Standard of care pain management will be compared to standard of care plus intravenous ketorolac.
Detailed description
Patients hospitalized for acute pancreatitis and admitted to an internal medicine team will be eligible for study. Patients enrolled will be blindly randomized to receive open-label pain management of standard of care or standard of care plus intravenous ketorolac. Patients will be enrolled between hour 24 and 48 of hospitalization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Patients receiving standard of care pain management including opioids. |
| Ketorolac | Active comparator | Drug: KetorolacPatients will receive standard of care pain management plus intravenous ketorolac. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years old
- opioid order for pain secondary to acute pancreatitis
- diagnosis of acute pancreatitis defined by the presence of two of the following three criteria: abdominal pain, lipase > 3x upper limit of normal, and/or findings of AP on imaging
- a patient with acute-on-chronic pancreatitis that does not exhibit elevated lipase levels is eligible for inclusion if the patient has the other two criteria
- received at least 3 L of IV crystalloid fluid within first 24 hours of admission to ensure patients have received initial volume expansion
Key exclusion criteria (15 listed)
- history of chronic heart failure
- history of acute coronary syndrome (ST-elevation myocardial infarction (STEMI) or non-ST elevation myocardial infarction (NSTEMI)) within last 6 months
- history of ischemic or hemorrhagic stroke within last 6 months
- history of upper gastrointestinal bleed (GI) within last 6 months
- history of inflammatory bowel disease
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 |
|---|---|---|
| Ketorolacintravenous ketorolac 30 mg every 6 hours | Drug | Ketorolac |
Primary outcome
Opioid use during study enrollment
Time frame: day 1 to day 5 of study
oral morphine equivalents (OME)
2 secondary outcomes
Day-to-day oral morphine equivalents
Time frame: day 1 to day 5 of study
Duration of intravenous opioid use
Time frame: During hospital admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Anthony J Gentene, PharmD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketorolac in people with Acute Pancreatitis, run by University of Cincinnati 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 7 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 8 Dec 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Opioid use during study enrollment (time frame: day 1 to day 5 of study). 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 8 Dec 2020.