Fifty patients aged 0-15 years with gastrointestinal bleeding will be recruited in the study regarding inclusion and exclusion criteria. The patients will be admitted to Mofid children hospital and will receive the therapeutic dose of Pantoprazole, then will be randomly divided into two intervention and control groups; in the intervention group, patients will receive 1 to 2 μg / kg octreotide, and in the control group, placebo will be prescribed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of GI bleeding, age under 15 years, hemodynamic stability.
Exclusion criteria: abnormal levels of liver enzymes and bilirubin,
variceal gastrointestinal bleeding, a known case of gastrointestinal varices,
hepatomegaly or splenomegaly in the evaluation, chronic liver disease grade C in child pugh score.
Intervention groups
Intervention group: receiving the therapeutic dose of Pantoprazole and 1 to 2 μg / kg octreotide,
Control group: receiving the therapeutic dose of Pantoprazole and placebo.
Main outcome variables
hemoglobin range during treatment, need of receiving blood, rebleeding during hospitalization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120415009475N6
Registration date:2019-02-14, 1397/11/25
Registration timing:retrospective
Last update:2019-02-14, 1397/11/25
Update count:1
Registration date
2019-02-14, 1397/11/25
Registrant information
Name
Bahador Mirrahimi
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Faculty of Pharmacy
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 0118
Email address
mirrahimi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial for comparing standard treatment for non-variceal upper GI bleeding with and without Octreotide in pediatrics
Public title
comparing the effect of Octreotide on non-variceal GI bleeding in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
diagnosis of GI bleeding
age under 15 years
hemodynamic stability
Exclusion criteria:
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
Age
To 15 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
the randomization has been performed using the permuted block randomization table.
Blinding (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
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.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
institutional ethics committee for Pharmacy, Nursing and midwifery schools
Street address
2nd floor, School of Nursing and Midwifery, Valiasr and Niayesh junction
City
Tehran
Province
Tehran
Postal code
1546815514
Approval date
2017-07-01, 1396/04/10
Ethics committee reference number
IR.SBMU.PHNM.1396.734
Health conditions studied
1
Description of health condition studied
Gastrointestinal bleeding in children
ICD-10 code
K29.01
ICD-10 code description
Acute (erosive) gastritis with haemorrhage
Primary outcomes
1
Description
Stop gastrointestinal bleeding
Timepoint
every hour until bleeding stops
Method of measurement
gastric lavage
Secondary outcomes
1
Description
Need for blood transfusion
Timepoint
24 hours before until 48 hours after intervention
Method of measurement
Volume of blood infusion (milliliter per kilogram)
2
Description
hemoglobin level
Timepoint
daily during admission
Method of measurement
complete blood count
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid children's Hospital
Full name of responsible person
Bahador Mirrahimi
Street address
تقاطع خیابان شریعتی و میرداماد،بیمارستان مفید
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2222 7029
Email
mirrahimi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Seyed Ali Ziaee
Street address
3rd Floor, Faculty of medicine, Arabi Ave, Daneshjoo Blvd, Velenjak.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 2040
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?