Clinical trial NCT05664074: Rectal Indomethacin vs Intravenous Ketorolac
Official title: Post ERCP Pancreatitis Prophylaxis, Effectiveness of Rectal Indomethacin vs Intravenous Ketorolac in the Pediatric Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Post-ERCP Acute Pancreatitis
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 192
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a prospective study where patients will be randomized into either rectal indomethacin or IV ketorolac.
Primary purpose: PREVENTION

Brief 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.


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

Primary outcomes:
measure: Post-ERCP Pancreatitis
timeFrame: 2 weeks
Secondary outcomes:
measure: Pain assessed by FLACC or NRS scoring post ERCP
timeFrame: 2 weeks
measure: Laboratory markers associated PEP (Amylase and Lipase)
timeFrame: 2 weeks
measure: Length of stay
timeFrame: 2 weeks
measure: Severity of pancreatitis (mild, moderately severe, severe)
timeFrame: 2 weeks
measure: C-Reactive Protein (CRP) level
timeFrame: 2 weeks
measure: Post-ERCP bleeding
timeFrame: 2 weeks
measure: White Blood Cell
timeFrame: 2 weeks
measure: Red Blood Cell
timeFrame: 2 weeks
measure: Hemoglobin
timeFrame: 2 weeks
measure: Hematocrit
timeFrame: 2 weeks
measure: MCV
timeFrame: 2 weeks
measure: MCH
timeFrame: 2 weeks
measure: MCHC
timeFrame: 2 weeks
measure: RDW
timeFrame: 2 weeks
measure: PLATELET
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: David Vitale, MD
role: PRINCIPAL_INVESTIGATOR
References: