Abstract
Background: Octreotide as somatostatin analogue decrease the production of gastrointestinal (GI) peptides. Its consumption in pediatric population has been limited to control of bleeding episodes with variceal origin. In this randomized controlled trial, we aim to assess octreotide as an add-on therapy to conventional regimen of proton pump inhibitors in controlling upper GI bleeding in pediatric population.Methods: In a prospective randomized controlled clinical trial, in Mofid Children's Hospital, Tehran, Iran, pediatric patients with age of 0 to 15 years diagnosed with acute non-variceal upper GI bleeding allocated to receive Octreotide or placebo and pantoprazole concomitantly. Medication administration initiated after patient’s stabilization. Patients with hepatic failure, liver stigma, coagulopathy thrombocytopenia etc. were excluded. Demographic, clinical and preclinical data were recorded in prepared sheets. All patients were followed until therapy discontinuation.Results: Forty-three patients with the mean age of 4.98 ± 3.79 years with confirmed non-variceal upper GI bleeding included to the study. Most patients had no specific etiology for their bleeding episode. Patients in intervention and control group received pantoprazole in comparable doses. No differences in baseline hemoglobin values was observed but final hemoglobin values were higher in intervention group. No differences in bleeding duration observed. In regard of adverse drug reaction due to octreotide infusion, none was observed in any patient. Conclusions: Our study demonstrated that octreotide does not alter bleeding duration but need for transfusion in non-variceal upper GI bleeding but it may have effect on amount of blood loss.Trial registration: The study was registered in Iranian Registry of Clinical Trial by the code of IRCT20120415009475N6.
Octreotide Safety and Efficacy in Pediatric Non-variceal Upper Gastrointestinal Bleeding, A Randomized Controlled Trial