IV Ibuprofen for the Prevention of Post-ERCP Pancreatitis

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.