IV Ibuprofen for the Prevention of Post-ERCP Pancreatitis

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-09-30

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.

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Detailed Description

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Conditions

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Post-ERCP Acute Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ibuprofen

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

Group Type EXPERIMENTAL

Ibuprofen

Intervention Type DRUG

Placebo

Single dose IV normal saline

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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Ibuprofen

Intervention Type DRUG

placebo

Intervention Type DRUG

Other Intervention Names

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Caldolor Normal Saline

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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No