Post-ERCP Acute PancreatitisPhase 4NCT05664074
Rectal Indomethacin vs Intravenous Ketorolac
A Phase 4 study testing Rectal indomethacin and IV ketorolac in people with Post-ERCP Acute Pancreatitis, run by David Vitale MD at 1 site in United States.
Trial summary
Endoscopic retrograde cholangiopancreatography (ERCP) is an essential procedure that can be complicated by post-ERCP pancreatitis (PEP). Indomethacin and ketorolac are two medications used to prevent PEP. The main reason for this research study is to compare the effectiveness these drugs at reducing rates of PEP. Read more about this study
- Who is it for?
- Ages 6 months to 21 years
- Conditions the study is for
- Post-ERCP Acute Pancreatitis
- What is being tested?
- Rectal indomethacin and IV ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2022to 5 Feb 2025
- Phase
- Phase 4
- 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 6 months to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Any patient undergoing ERCP (diagnostic or therapeutic with cannulation of the major or minor papilla)
- Age 6 month- 21 years old
- Does not meet exclusion criteria
Who cannot join
- < 10 kg
- Low risk subgroup: Biliary indication with history of prior biliary sphincterotomy.
- High risk for bleeding (Example: Planned liver biopsy)
- Gastrointestinal bleeding in previous 3 days
- Acute pancreatitis (within 3 days) at the time of ERCP
- Use of NSAIDs in the previous 5 days
Show all 12Show fewer
- Peptic ulcer disease
- Acute kidney Injury or Known Chronic Kidney Disease per KDIGO
- Pregnancy (Pregnancy tests are administered prior to ERCP as standard of care)
- Lithium therapy
- Allergy to ketorolac or indomethacin
- Organ Dysfunction or SIRS
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Post ERCP Pancreatitis Prophylaxis, Effectiveness of Rectal Indomethacin vs Intravenous Ketorolac in the Pediatric Population
Endoscopic retrograde cholangiopancreatography (ERCP) is an essential procedure that can be complicated by post-ERCP pancreatitis (PEP). Indomethacin and ketorolac are two medications used to prevent PEP. The main reason for this research study is to compare the effectiveness these drugs at reducing rates of PEP. There have been no studies comparing the effectiveness of these medications in preventing PEP in pediatric patients. You are being asked to take part in this research study because you are scheduled to have an ERCP as part of your medical care.
- Conditions
- Post-ERCP Acute Pancreatitis
- Being tested
- Rectal indomethacin, IV ketorolac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal indomethacinDrug
Dosage based on subject's weight:
>=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg
IV ketorolacDrug
Dosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg)
| Study group | Role | What they receive |
|---|---|---|
| Rectal indomethacin | Experimental | Dosage based on subject's weight:
>=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg Receives: Drug: Rectal indomethacin |
| IV ketorolac | Experimental | Dosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg) Receives: Drug: IV ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-ERCP Pancreatitis
Below is the number of participants within the rectal indomethacin and IV ketorolac cohorts who developed Post-ERCP Pancreatitis-
Post ERCP Pancreatitis: A patient must have at least 2 of the following to establish a diagnosis of post ERCP pancreatitis:
- Characteristic physical exam findings- pain worse than admission per pain scales (please see point 2) and/or nausea
- Amylase (unit/L) or lipase(unit/L) greater than 3 times the age appropriate upper limit of normal.
- Normal range of amylase (15-127 unit/L)
- Normal range of lipase (12-50 unit/L)
- Confirmatory imaging (Ultrasound, CT or MRI) that suggests or demonstrates pancreatic inflammation
Measured: 2 weeks
Post-ERCP Pancreatitis: Pancreatic Duct Injections
86 participants from the rectal indomethacin cohort and 83 from IV ketorolac received pancreatic duct injections during their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who received pancreatic duct injections.
Measured: 2 weeks
Post-ERCP Pancreatitis: Native Papilla
36 participants from the rectal indomethacin cohort and 33 from IV ketorolac had a native papilla for their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who had a native papilla.
Measured: 2 weeks
Post-ERCP Pancreatitis: Pancreatic Sphincterotomy
25 participants from the rectal indomethacin cohort and 19 from IV ketorolac received pancreatic sphincterotomies during their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who received pancreatic sphincterotomies.
Measured: 2 weeks
Post-ERCP Pancreatitis: Opti-Ray Amount
83 participants from the rectal indomethacin cohort and 84 from IV ketorolac received various amounts of Opti-Ray during their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who received Opti-Ray.
Measured: 2 weeks
Post-ERCP Pancreatitis: Therapeutic Pancreatic Duct Stent Placed
51 participants from the rectal indomethacin cohort and 53 from IV ketorolac received a therapeutic pancreatic duct stent during their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who received therapeutic pancreatic duct stents.
Measured: 2 weeks
Post-ERCP Pancreatitis: Prophylactic Pancreatic Duct Stent Placed
11 participants from the rectal indomethacin cohort and 11 from IV ketorolac received a prophylactic pancreatic duct stent during their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who received prophylactic pancreatic duct stents.
Measured: 2 weeks
Secondary outcomes (7)
Pain Assessed by FLACC or NRS Scoring Post ERCP: PACU
A minimum of 3 pain assessments were completed by nursing staff/anesthesia during admission:
Anesthesia/ PACU- initial pain assessment Evening-2100- pain assessment by RN Morning -0800- pain assessment by RN
We defined *Pain score > 0 (any pain) for patients in the rectal indomethacin vs. IV ketorolac cohorts using the NRS and FLACC Pain scale.
Face, Legs, Activity, Cry, and Consolability (FLACC) Pain scale for patients 0-5 years of age and patients unable to verbalize pain
Numeric Rating Scale (NRS) Pain scale for patients 6 years old and above
- Mild- 0 to 3
- Moderate- 4 to 6
- Severe- 7 to 10
Measured: 2 weeks
Pain Assessed by FLACC or NRS Scoring Post ERCP: Evening
Not all patients were admitted following the procedure which accounts for the difference in overall number of participants analyzed.
A minimum of 3 pain assessments were completed by nursing staff/anesthesia during admission:
Anesthesia/ PACU- initial pain assessment Evening-2100- pain assessment by RN Morning -0800- pain assessment by RN
We defined *Pain score > 0 (any pain) for patients in the rectal indomethacin vs. IV ketorolac cohorts using the NRS and FLACC Pain scale.
Face, Legs, Activity, Cry, and Consolability (FLACC) Pain scale for patients 0-5 years of age and patients unable to verbalize pain
Numeric Rating Scale (NRS) Pain scale for patients 6 years old and above
- Mild- 0 to 3
- Moderate- 4 to 6
- Severe- 7 to 10
Measured: 2 weeks
Pain Assessed by FLACC or NRS Scoring Post ERCP: Morning
Not all patients were admitted following the procedure which accounts for the difference in overall number of participants analyzed.
A minimum of 3 pain assessments were completed by nursing staff/anesthesia during admission:
Anesthesia/ PACU- initial pain assessment Evening-2100- pain assessment by RN Morning -0800- pain assessment by RN
We defined *Pain score > 0 (any pain) for patients in the rectal indomethacin vs. IV ketorolac cohorts using the NRS and FLACC Pain scale.
Face, Legs, Activity, Cry, and Consolability (FLACC) Pain scale for patients 0-5 years of age and patients unable to verbalize pain
Numeric Rating Scale (NRS) Pain scale for patients 6 years old and above
- Mild- 0 to 3
- Moderate- 4 to 6
- Severe- 7 to 10
Measured: 2 weeks
Laboratory Markers Associated With PEP ( Lipase)
Lipase (unit/L)
Measured: 2 weeks
Laboratory Markers Associated With PEP (Amylase)
Amylase value in unit/L
Measured: 2 weeks
Length of Stay
Below is the median length of stay for participants within the rectal indomethacin and IV ketorolac cohorts. The difference in participants analyzed is due to the fact that not all participants were admitted following the procedure.
Measured: 2 weeks
Severity of Pancreatitis (Mild, Moderately Severe, Severe)
Severity of AP will be classified as mild, moderately severe, or severe in accordance with the NASPGHAN Classification system.
- Mild: "AP that is not associated with any organ failure, local or systemic complications, and usually resolves within the first week after presentation."
- Moderately Severe: "AP with either the development of transient organ failure/dysfunction (lasting no >48 hours) or development of local or systemic complications. Local complications would include development of (peri) or pancreatic complications including fluid collections or necrosis. Systemic complications would include exacerbation of previously diagnosed co-morbid disease (such as lung disease or kidney disease)."
- Severe: "AP with development of organ dysfunction per International pediatric sepsis consensus conference (please see definition 9) that persists >48 hours. Persistent organ failure may be single or multiple, and may develop beyond the first 48 hours of presentation."
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start7 Nov 2022
- Primary completion5 Feb 2025
- Study completion5 Feb 2025
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 Post-ERCP Acute PancreatitisStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a prospective study where patients will be randomized into either rectal indomethacin or IV ketorolac.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Vitale MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Vitale MD, Children's Hospital Medical Center, Cincinnati
- Investigators
- David Vitale, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664074
- Sponsor's protocol ID
- 2022-0640
- Status last verified
- Mar 2026
- First submitted
- 23 Nov 2022
- Last updated
- 12 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post ERCP Pancreatitis Prophylaxis, Effectiveness of Rectal Indomethacin vs Intravenous Ketorolac in the Pediatric Population
- ClinicalTrials.gov ID
- NCT05664074
- Acronym / sponsor ID
- 2022-0640
- Conditions
- Post-ERCP Acute Pancreatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- David Vitale MDUniversity, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 5 Feb 2025 (actual)
- First posted
- 23 Dec 2022 (actual)
- Results
- Posted 12 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endoscopic retrograde cholangiopancreatography (ERCP) is an essential procedure that can be complicated by post-ERCP pancreatitis (PEP). Indomethacin and ketorolac are two medications used to prevent PEP. The main reason for this research study is to compare the effectiveness these drugs at reducing rates of PEP. There have been no studies comparing the effectiveness of these medications in preventing PEP in pediatric patients. You are being asked to take part in this research study because you are scheduled to have an ERCP as part of your medical care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This will be a prospective study where patients will be randomized into either rectal indomethacin or IV ketorolac.
| Arm | Type | Receives |
|---|---|---|
| Rectal indomethacin | Experimental | Drug: Rectal indomethacinDosage based on subject's weight: >=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg |
| IV ketorolac | Experimental | Drug: IV ketorolacDosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg) |
Who may qualify
- Ages
- 6 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Any patient undergoing ERCP (diagnostic or therapeutic with cannulation of the major or minor papilla)
- Age 6 month- 21 years old
- Does not meet exclusion criteria
Key exclusion criteria (12 listed)
- < 10 kg
- Low risk subgroup: Biliary indication with history of prior biliary sphincterotomy.
- High risk for bleeding (Example: Planned liver biopsy)
- Gastrointestinal bleeding in previous 3 days
- Acute pancreatitis (within 3 days) at the time of ERCP
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 |
|---|---|---|
| Rectal indomethacinDosage based on subject's weight: >=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg | Drug | Rectal indomethacin |
| IV ketorolacDosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg) | Drug | IV ketorolac |
Primary outcome
Post-ERCP Pancreatitis
Time frame: 2 weeks
Below is the number of participants within the rectal indomethacin and IV ketorolac cohorts who developed Post-ERCP Pancreatitis- Post ERCP Pancreatitis: A patient must have at least 2 of the following to establish a diagnosis of post ERCP pancreatitis: 1. Characteristic physical exam findings- pain worse than admission per pain scales (please see point 2) and/or nausea 2. Amylase (unit/L) or lipase(unit/L) greater than 3 times the age appropriate upper limit of normal. * Normal range of amylase (15-127 unit/L) * Normal range of lipase (12-50 unit/L) 3. Confirmatory imaging (Ultrasound, CT or MRI) that suggests or demonstrates pancreatic inflammation
Post-ERCP Pancreatitis: Pancreatic Duct Injections
Time frame: 2 weeks
86 participants from the rectal indomethacin cohort and 83 from IV ketorolac received pancreatic duct injections during their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who received pancreatic duct injections.
Post-ERCP Pancreatitis: Native Papilla
Time frame: 2 weeks
36 participants from the rectal indomethacin cohort and 33 from IV ketorolac had a native papilla for their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who had a native papilla.
Post-ERCP Pancreatitis: Pancreatic Sphincterotomy
Time frame: 2 weeks
25 participants from the rectal indomethacin cohort and 19 from IV ketorolac received pancreatic sphincterotomies during their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who received pancreatic sphincterotomies.
Post-ERCP Pancreatitis: Opti-Ray Amount
Time frame: 2 weeks
83 participants from the rectal indomethacin cohort and 84 from IV ketorolac received various amounts of Opti-Ray during their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who received Opti-Ray.
Post-ERCP Pancreatitis: Therapeutic Pancreatic Duct Stent Placed
Time frame: 2 weeks
51 participants from the rectal indomethacin cohort and 53 from IV ketorolac received a therapeutic pancreatic duct stent during their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who received therapeutic pancreatic duct stents.
Post-ERCP Pancreatitis: Prophylactic Pancreatic Duct Stent Placed
Time frame: 2 weeks
11 participants from the rectal indomethacin cohort and 11 from IV ketorolac received a prophylactic pancreatic duct stent during their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who received prophylactic pancreatic duct stents.
7 secondary outcomes
Pain Assessed by FLACC or NRS Scoring Post ERCP: PACU
Time frame: 2 weeks
Pain Assessed by FLACC or NRS Scoring Post ERCP: Evening
Time frame: 2 weeks
Pain Assessed by FLACC or NRS Scoring Post ERCP: Morning
Time frame: 2 weeks
Laboratory Markers Associated With PEP ( Lipase)
Time frame: 2 weeks
Laboratory Markers Associated With PEP (Amylase)
Time frame: 2 weeks
Length of Stay
Time frame: 2 weeks
Severity of Pancreatitis (Mild, Moderately Severe, Severe)
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David Vitale, MD principal investigator
Children's Hospital Medical Center, 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 Rectal indomethacin and IV ketorolac in people with Post-ERCP Acute Pancreatitis, run by David Vitale MD 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 12 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: finished, as of the sponsor's last update on 12 Mar 2026. 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?
Yes. Results are posted in the registry (first posted 12 Mar 2026). 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?
Post-ERCP Pancreatitis (time frame: 2 weeks). The study lists 7 primary outcomes in all. 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 12 Mar 2026.