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Which drug best prevents pancreatitis in kids after ERCP?

NCT ID NCT05664074

Prevention Sponsor: David Vitale MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at 192 children having an ERCP procedure to see which drug—rectal indomethacin or IV ketorolac—better prevents post-ERCP pancreatitis. Both are anti-inflammatory medicines given before the procedure. The goal is to find the most effective option for kids.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rectal indomethacin and intravenous ketorolac
What this could lead to
If this trial shows one drug is better, it could help doctors choose the best way to prevent pancreatitis after ERCP in children.
What could go wrong
This is a completed Phase 4 trial with 192 children, but results may not apply to all patients. Both drugs have known side effects like bleeding risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

192 people

The number who actually took part.

Started

Nov 2022

Finished

Feb 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months to 21 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute pancreatitis prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Post-ercp acute pancreatitis

Contacts and locations

Locations

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.