Phase 4
Completed N=192
Rectal Indomethacin vs Intravenous Ketorolac
Post-ERCP Acute Pancreatitis
Source: ClinicalTrials.gov NCT05664074 ↗
Enrolled (actual)
192
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcomePrimary: Post-ERCP Pancreatitis — 15; 21 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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. 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-ERCP Pancreatitis |
15; 21 | — |
| PRIMARY Post-ERCP Pancreatitis: Pancreatic Duct Injections |
14; 19; 72; 64 | — |
| PRIMARY Post-ERCP Pancreatitis: Native Papilla |
11; 15; 25; 18 | — |
| PRIMARY Post-ERCP Pancreatitis: Pancreatic Sphincterotomy |
9; 13; 16; 6 | — |
| PRIMARY Post-ERCP Pancreatitis: Opti-Ray Amount |
7.5; 7; 4; 3.8 | — |
| PRIMARY Post-ERCP Pancreatitis: Therapeutic Pancreatic Duct Stent Placed |
5; 8; 46; 45 | — |
| PRIMARY Post-ERCP Pancreatitis: Prophylactic Pancreatic Duct Stent Placed |
5; 7; 6; 4 | — |
| SECONDARY Pain Assessed by FLACC or NRS Scoring Post ERCP: PACU |
9; 8 | — |
| SECONDARY Pain Assessed by FLACC or NRS Scoring Post ERCP: Evening |
22; 23 | — |
| SECONDARY Pain Assessed by FLACC or NRS Scoring Post ERCP: Morning |
28; 27 | — |
| SECONDARY Laboratory Markers Associated With PEP ( Lipase) |
159; 204 | — |
| SECONDARY Laboratory Markers Associated With PEP (Amylase) |
126; 143 | — |
| SECONDARY Length of Stay |
1; 1 | — |
| SECONDARY Severity of Pancreatitis (Mild, Moderately Severe, Severe) |
15; 20; 0; 1; 0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05664074). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.