IV Ibuprofen for the Prevention of Post-ERCP Pancreatitis

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.

Study Overview

• Status: Terminated
• Conditions: Post-ERCP Acute Pancreatitis
• Intervention / Treatment: Drug: placebo; Drug: Ibuprofen

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • Children's Medical Center of Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increased Pain Score	Number of patients with increased pain scores after the procedure	pre-procedural, 24 hours
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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: David M Troendle, MD, UT Southwestern Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: September 11, 2014
• First Submitted That Met QC Criteria: September 11, 2014
• First Posted (Estimate): September 16, 2014

Study Record Updates

• Last Update Posted (Actual): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 5, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: pediatric; ibuprofen; post-ERCP pancreatitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: STU 082014-033