IV Ibuprofen for the Prevention of Post-ERCP Pancreatitis

Study Overview
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Brief Summary
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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.

Official Title
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IV Ibuprofen for the Prevention of Post-ERCP Pancreatitis

Conditions
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Post-ERCP Acute Pancreatitis

Intervention / Treatment
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* Drug: Ibuprofen
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibuprofen<br>Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg). | Drug: Ibuprofen<br> <br> * Other names: Caldolor;|
| Placebo Comparator: Placebo<br>Single dose IV normal saline | Drug: placebo<br> <br> * Other names: Normal Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-ERCP Pancreatitis | Number of patients who develop post-ERCP pancreatitis | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-ERCP Bleeding | Number of patients who develop post-ERCP bleeding | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post-ERCP pancreatitis, pediatric, ibuprofen