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IV Ibuprofen for the Prevention of Post-ERCP Pancreatitis

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ClinicalTrials.gov Identifier: NCT02241512
Recruitment Status : Terminated (lack of funding)
First Posted : September 16, 2014
Last Update Posted : January 1, 2019
Sponsor:
Information provided by (Responsible Party):
David M Troendle, University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment Phase
Post-ERCP Acute Pancreatitis Drug: Ibuprofen Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: IV Ibuprofen for the Prevention of Post-ERCP Pancreatitis
Study Start Date : September 2014
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Experimental: Ibuprofen
Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg).
Drug: Ibuprofen
Other Name: Caldolor

Placebo Comparator: Placebo
Single dose IV normal saline
Drug: placebo
Other Name: Normal Saline




Primary Outcome Measures :
  1. Number of patients who develop post-ERCP pancreatitis [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Number of patients who develop post-ERCP bleeding [ Time Frame: 2 weeks ]

Other Outcome Measures:
  1. Change between pre-procedural and post-procedural pain scores at 24 hours [ Time Frame: pre-procedural, 24 hours ]


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02241512


Locations
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United States, Texas
Children's Medical Center of Dallas
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: David M Troendle, MD UT Southwestern Medical Center

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Responsible Party: David M Troendle, Dr., University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02241512     History of Changes
Other Study ID Numbers: STU 082014-033
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: January 1, 2019
Last Verified: December 2018
Keywords provided by David M Troendle, University of Texas Southwestern Medical Center:
post-ERCP pancreatitis
pediatric
ibuprofen
Additional relevant MeSH terms:
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Ibuprofen
Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action