IV Ibuprofen for the Prevention of Post-ERCP Pancreatitis

The University of Texas System (UT)

Status and phase: Terminated; Phase 2

Conditions: Post-ERCP Acute Pancreatitis

Treatments: Drug: placebo; Drug: Ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT02241512

STU 082014-033

Details and patient eligibility

About

Endoscopic retrograde cholangiopancreatography (ERCP) is an advanced endoscopic technique utilized to diagnose and treat pathologic conditions involving the ducts draining the liver and pancreas. Post-ERCP pancreatitis (PEP) is the most common complication following ERCP and occurs in approximately 11% of children undergoing the procedure. By definition it leads to prolongation of hospital stay or delays in care and rarely can result in long-term morbidity or even death. Recent adult trials have demonstrated prevention of PEP with administration of rectal nonsteroidal anti-inflammatory drugs (NSAIDS). To date, no studies have been performed in children thus no "gold standard" or even commonly accepted method of preventing PEP in the pediatric population exist. Studying an IV NSAID such as ibuprofen has distinct advantages over rectally administered NSAIDs in the pediatric population in that it would allow for more consistent weight based dosing and would have more predictable absorption compared to suppository. Thus, this project proposes a pilot study evaluating the effectiveness of IV ibuprofen at preventing PEP in the pediatric population. The design of the proposed study is a prospective randomized double-blind trial comparing IV Ibuprofen to placebo controls (normal saline) at the time of procedure in patients undergoing ERCP at Children's Medical Center Dallas over a two-year period. The primary outcome measurement will be development of PEP. Post-ERCP bleeding and change in pre- and post- procedural pain scores will also be measured. The hypothesis is that IV Ibuprofen administered at the time of ERCP will decrease rates of post-ERCP pancreatitis in pediatric patients.

Enrollment: 69 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age<=18 years
• Undergoing ERCP (defined as cannulation of the major or minor papilla) for any indication

Exclusion criteria

• Age>18
• Pancreatitis within the 72 hours preceding ERCP
• Allergy or hypersensitivity to Aspirin or NSAID medications
• Pregnancy or breastfeeding mother
• Cr >1.4
• Gastrointestinal hemorrhage in preceding 72 hours
• Heart disease reliant upon a patient ductus arteriosis
• History of sickle cell disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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69 participants in 2 patient groups, including a placebo group

Ibuprofen

Experimental group

Description:

Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg).

Treatment:

Drug: Ibuprofen

Placebo

Placebo Comparator group

Description:

Single dose IV normal saline

Treatment:

Drug: placebo