IV Ibuprofen for the Prevention of Post-ERCP Pancreatitis: A Pilot Study
Study ID: STU 082014-033
This project proposes a pilot study evaluating the effectiveness of iV ibuprofen at preventing PeP in the pediatric population. The goal of the study is to gather preliminary data to allow sample size calculations for a future multi-center trial and evaluate the safety of administering iV ibuprofen at the time of eRCP. The design of the proposed study is a prospective randomized double-blind control trial comparing iV ibuprofen to placebo (normal saline) at the time of procedure in all patients undergoing eRCP at Children's Medical Center over a two year period. iV ibuprofen will be given as a single dose of 10mg/kg (max: 800mg) at the time of endoscopy. it will be drawn up from a single use vial and diluted with normal saline to a concentration of 4mg/ml and will be infused over a 15 minute time period. Those assigned to receive the placebo control will receive an equivalent amount of normal saline only over the same time period. 128 eligible patients are expected to be encountered over the two-year study period. a total of 120 patients will be consented for this study (60 to receive placebo, 60 to receive iV ibuprofen). The main outcome measurement will be development of PeP. Rates of post-eRCP bleeding will also be measured as a secondary safety endpoint. The results of this study will be utilized for the developing a larger multicenter study.
Age<=18 years Undergoing ERCP (defined as cannulation of the major or minor papilla) for any indication