Clinical trial NCT02241512: IV Ibuprofen for the Prevention of Post-ERCP Pancreatitis
Official title: IV Ibuprofen for the Prevention of Post-ERCP Pancreatitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Post-ERCP Acute Pancreatitis
Keywords: post-ERCP pancreatitis
pediatric
ibuprofen
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 69
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Post-ERCP Pancreatitis
timeFrame: 2 weeks
Secondary outcomes:
measure: Post-ERCP Bleeding
timeFrame: 2 weeks
Other outcomes:
measure: Increased Pain Score
timeFrame: pre-procedural, 24 hours
measure: 24-h Post-ERCP Pain Score
timeFrame: pre-procedural, 24 hours
Locations:
city: Dallas
country: United States
facility: Children's Medical Center of Dallas
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: David M Troendle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Troendle DM, Gurram B, Huang R, Barth BA. IV Ibuprofen for Prevention of Post-ERCP Pancreatitis in Children: A Randomized Placebo-controlled Feasibility Study. J Pediatr Gastroenterol Nutr. 2020 Jan;70(1):121-126. doi: 10.1097/MPG.0000000000002524.