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IRCT20120415009475N6 IRCT 2019-02-14 Shahid Beheshti University of Medical Sciences comparing the effect of Octreotide on non-variceal GI bleeding in children Clinical trial for comparing standard treatment for non-variceal upper GI bleeding with and without Octreotide in pediatrics 2017-11-22 anticipated 50 Complete https://irct.ir/trial/10069 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: All patients will be visited by a physician and patients' demographic characteristics including Age, Sex, weight, height, co-morbidities, and clinical findings including coagulation status, gastrointestinal disease history, endoscopic findings, hemoglobin range during treatment, need of receiving blood, and also dose and duration of treatment with octreotide will be recorded. Also, duration of hospitalization, patient outcome, re-bleeding during hospitalization, failure of treatment defined as a recurrence of bleeding or continuous bleeding during treatment will be recorded, Randomization description: the randomization has been performed using the permuted block randomization table, Blinding description: The medication and placebo will be in look-alike coded packages, and the codes based on the permuted block randomization table will be provided to the researcher by a designated person via phone. At the end of the study, after organizing the data by the same person, the statistical expert will perform the analysis. Then, the code packet will be opened, and the final results will be reported. 2 Gastrointestinal bleeding in children. Intervention 1: Intervention group: patients will receive 1 to 2 micrograms of Octreotide per kilogram of body weight per hour until the cessation of bleeding. Every 50 micrograms will be infused in 50 milliliters of normal saline as a one milliliter per kilogram weight per hour. Intervention 2: Control group: patients will receive placebo ampule in 50 milliliters of normal saline infused as a 1 milliliter per kilogram weight per hour until the cessation of bleeding. Yes - There is a plan to make this available What will be shared: The main outcome will be available. When: Six months after publishing data. To whom: The data will be available per request for people working in academic institutions. Conditions: The data will available for using in systematic review and meta-analysis. Where to obtain: The data will be available by contacting email; mirrahimi@sbmu.ac.ir. How to obtain: The data will available for using in systematic review and meta-analysis. Comments:
public Azin Hemmati
Valiasr street, Niayesh junction.
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2222 7021 hemmati.azin@ymail.com Shahid Beheshti University of Medical Sciences scientific Dr Pejman Rouhani
Shariati Ave, Mirdamad junction
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2222 7021 rohanipejman@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) diagnosis of GI bleeding age under 15 years hemodynamic stability no limit 15 years Both abnormal levels of liver enzymes and bilirubin variceal gastrointestinal bleeding Known case of gastrointestinal varices Hepatomegaly or splenomegaly in evaluation chronic liver disease grade C in child pugh score K29.01 Acute (erosive) gastritis with haemorrhage Treatment - Drugs Treatment - Drugs Intervention group: patients will receive 1 to 2 micrograms of Octreotide per kilogram of body weight per hour until the cessation of bleeding. Every 50 micrograms will be infused in 50 milliliters of normal saline as a one milliliter per kilogram weight per hour. Control group: patients will receive placebo ampule in 50 milliliters of normal saline infused as a 1 milliliter per kilogram weight per hour until the cessation of bleeding. Stop gastrointestinal bleeding. Timepoint: every hour until bleeding stops. Method of measurement: gastric lavage. Need for blood transfusion. Timepoint: 24 hours before until 48 hours after intervention. Method of measurement: Volume of blood infusion (milliliter per kilogram). Hemoglobin level. Timepoint: daily during admission. Method of measurement: complete blood count. Shahid Beheshti University of Medical Sciences Approved 2017-07-01 institutional ethics committee for Pharmacy, Nursing and midwifery schools 2nd floor, School of Nursing and Midwifery, Valiasr and Niayesh junction Tehran Tehran Iran (Islamic Republic of)