Rectal Indomethacin vs Intravenous Ketorolac

March 10, 2026 updated by: David Vitale MD

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
192

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 17 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • < 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Rectal indomethacin

Dosage based on subject's weight:

>=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg
Drug: Rectal indomethacin

Dosage based on subject's weight:

>=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg
Experimental: IV ketorolac
Dosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg)
Drug: IV ketorolac
Dosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
2 weeks
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.
2 weeks
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.
2 weeks
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.
2 weeks
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.
2 weeks
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.
2 weeks
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.
2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain Assessed by FLACC or NRS Scoring Post ERCP: PACU
Time Frame: 2 weeks

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

  1. Mild- 0 to 3
  2. Moderate- 4 to 6
  3. Severe- 7 to 10
2 weeks
Pain Assessed by FLACC or NRS Scoring Post ERCP: Evening
Time Frame: 2 weeks

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

  1. Mild- 0 to 3
  2. Moderate- 4 to 6
  3. Severe- 7 to 10
2 weeks
Pain Assessed by FLACC or NRS Scoring Post ERCP: Morning
Time Frame: 2 weeks

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

  1. Mild- 0 to 3
  2. Moderate- 4 to 6
  3. Severe- 7 to 10
2 weeks
Laboratory Markers Associated With PEP ( Lipase)
Time Frame: 2 weeks
Lipase (unit/L)
2 weeks
Laboratory Markers Associated With PEP (Amylase)
Time Frame: 2 weeks
Amylase value in unit/L
2 weeks
Length of Stay
Time Frame: 2 weeks
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.
2 weeks
Severity of Pancreatitis (Mild, Moderately Severe, Severe)
Time Frame: 2 weeks

Severity of AP will be classified as mild, moderately severe, or severe in accordance with the NASPGHAN Classification system.

  1. Mild: "AP that is not associated with any organ failure, local or systemic complications, and usually resolves within the first week after presentation."
  2. 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)."
  3. 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."
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
David Vitale MD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Vitale, MD, Children's Hospital Medical Center, Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 7, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 5, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 5, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-0640

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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