IV Ibuprofen for the Prevention of Post-ERCP Pancreatitis

Post-ERCP Acute Pancreatitis Clinical Trial

Official title:

IV Ibuprofen for the Prevention of Post-ERCP Pancreatitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02241512
• Other study ID #: STU 082014-033
• Status: Terminated
• Phase: Phase 2
• Start date: September 2014
• Est. completion date: September 2018

Study information

• Verified date: February 2020
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 69
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatitis
• Post-ERCP Acute Pancreatitis

Intervention

Drug:
• Ibuprofen

• placebo

Locations

Country	Name	City	State
United States	Children's Medical Center of Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Increased Pain Score	Number of patients with increased pain scores after the procedure	pre-procedural, 24 hours
Other	24-h Post-ERCP Pain Score	Pain score recorded 24-hrs after the ERCP was performed as recorded on a 10-point Likert pain scale (0= lowest value, no pain, 10=highest value, severe pain)	pre-procedural, 24 hours
Primary	Post-ERCP Pancreatitis	Number of patients who develop post-ERCP pancreatitis	2 weeks
Secondary	Post-ERCP Bleeding	Number of patients who develop post-ERCP bleeding	2 weeks