IV Ibuprofen for the Prevention of Post-ERCP Pancreatitis

NCT02241512 | Terminated Phase 2 Results DMC

• 1 other identifier: STU 082014-033
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-ERCP Acute Pancreatitis

Keywords

post-ERCP pancreatitis; pediatric; ibuprofen

Outcome Measures

Primary Outcomes (1)

• Post-ERCP Pancreatitis

  Number of patients who develop post-ERCP pancreatitis

  2 weeks

Secondary Outcomes (1)

• Post-ERCP Bleeding

  2 weeks

Other Outcomes (2)

• Increased Pain Score

  pre-procedural, 24 hours

• 24-h Post-ERCP Pain Score

  pre-procedural, 24 hours

Study Arms (2)

Ibuprofen

EXPERIMENTAL

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

Drug: Ibuprofen

Placebo

PLACEBO COMPARATOR

Single dose IV normal saline

Drug: placebo

Interventions

Ibuprofen DRUG

Also known as: Caldolor

Ibuprofen

placebo DRUG

Also known as: Normal Saline

Placebo

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age\<=18 years
• Undergoing ERCP (defined as cannulation of the major or minor papilla) for any indication

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Children's Medical Center of Dallas

Dallas, Texas, 75235, United States

Location

Related Publications (1)

• 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.

  PMID: 31651801 DERIVED

MeSH Terms

Interventions

Ibuprofen; Saline Solution

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. David Troendle
• Organization: UT Southwestern

david.troendle@utsouthwestern.edu

214456-8000

Study Officials

• David M Troendle, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: September 16, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: February 18, 2020
• Results First Posted: February 18, 2020

Record last verified: 2020-02

Locations

US (1)