Lactated Ringers With or Without Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

PHASE3CompletedINTERVENTIONAL
Enrollment

192

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

June 30, 2016

Study Completion Date

June 30, 2016

Conditions
Post-ERCP Acute Pancreatitis
Interventions
DRUG

Indomethacin

Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis

DRUG

Lactated Ringer's Solution

Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis

DRUG

Normal Saline

standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.

DRUG

Placebo

Placebo would be a suppository 50 mg x 2

Trial Locations (1)

08103

Cooper Hospital, Camden

All Listed Sponsors
lead

The Cooper Health System

OTHER

NCT02641561 - Lactated Ringers With or Without Rectal Indomethacin to Prevent Post-ERCP Pancreatitis | Biotech Hunter | Biotech Hunter