Octreotide Efficacy and Safety in Pediatric Non-variceal Upper Gastrointestinal Bleeding: A Randomized Placebo-Controlled Clinical Trial

Abstract

Background: Octreotide has been used to control bleeding episodes with variceal origin in the pediatric population. To date, there is no clear evidence of octreotide use for non-variceal bleeding in clinical trials. Objectives: We aimed to assess the octreotide efficacy as an add-on therapy to the conventional regimen of proton pump inhibitors for controlling upper non-variceal gastrointestinal (GI) bleeding in the pediatric population. Methods: This prospective randomized controlled clinical trial was performed on pediatric patients aged 1 - 15 years and diagnosed with acute non-variceal upper GI bleeding. The participants were allocated to receive octreotide or placebo and pantoprazole concomitantly. The study was conducted in Mofid Children’s Hospital, Tehran, Iran, during February 2019 - December 2019. Patients with hepatic failure, liver stigma, and coagulopathy due to thrombocytopenia were excluded. Demographic, clinical, and preclinical data were recorded in prepared sheets. All the patients were followed until therapy discontinuation. P-value < 0.05 was considered significant. Results: Forty-three patients with a mean age of 4.98 ± 3.79 years and confirmed non-variceal upper GI bleeding were included in the present study. Most patients had no specific etiology for their bleeding episodes. Patients in the intervention and control groups received pantoprazole in comparable doses. No differences were observed between the two groups in terms of baseline hemoglobin values (P = 0.08), while final hemoglobin values were significantly higher in the intervention group (P = 0.014). The bleeding duration was not significantly different between the two groups (P = 0.99). Moreover, none of the cases showed adverse drug reactions due to octreotide infusion. Conclusions: Our study demonstrated that octreotide did not alter bleeding duration or need for blood transfusion. However, positive results were observed for hemoglobin, affecting blood loss volume.