Comparison of the effect of pidrolax, paraffin and lactulose on chronic functional constipation in children aged 2-6 years referred to the pediatric clinic of Amirkabir Hospital

Compare the effect of pidrolax, paraffin and lactulose on chronic functional constipation in children aged 2 to 6 years referred to the pediatric clinic of Amirkabir Hospital

Clinical trial with three parallel groups, single-blind, randomized, phase 3 on 150 patients. Random blocking method is used for randomization.

In this study, children aged 2 to 6 years referred to the pediatric clinic of Amirkabir Hospital in Arak, who according to the diagnosis of pediatric gastroenterologist are suffering from chronic constipation and have the inclusion criteria; Enter the study. These children will be divided into three identical groups (pidrolax, lactulose, paraffin) randomly. Then, the information of each child, including age, gender, number of defecations per week, stool consistency, etc. is monitored serially by asking checklists from the child or parents, so the information statistically analyzed. This study (due to differences in the form and type of drugs) is a single-blind study. In addition, by naming groups, we blind those who evaluate the results of the study.

All children with chronic constipation for at least 6 months aged 2 to 6 years referred to the pediatric clinic of Amirkabir Hospital Parental consent Do not have any disease other than constipation

In the Pidrolax group, the child is given 0.7 gr per kg body weight orally in the morning of fasting. In the lactulose group 1 to 2 cc per kilogram daily and in the paraffin group, oral paraffin will be given in the amount of 0.5 cc per kg every 12 hours.

Number of defecation per week, stool consistency, number of abdominal pains per week, number of painful defection per week, anorexia and nausea. (Serial monitoring: before starting treatment, the first week after starting treatment, then every 2 weeks to two months)

Children 2 to 6 years old referred to the clinic who have been diagnosed with chronic constipation based on the ROME4 diagnostic criteria will be divided into three equal groups (pidrolax, lactulose, paraffin) using random allocation. This study will be randomized. In order to perform random allocation, random blocking method with 6 blocks such as AABBCC, ABBACC, BBAACC, AACCBB, BBCCAA, ACBCAB, etc. will be used, which will have numbers from 1 onwards, respectively. Then, by randomly selecting numbers from 1 to n , (n = number of possible cases of six blocks) , random sequences of three types of drugs will be identified for the study samples. Drug A means pidrolax, drug B is lactulose and drug C is paraffin.

This is a single-blind clinical trial study in which only the data analyzer is blinded and the data is provided to the data evaluator in groups A, B, and C. The patient, researcher, and clinical caregiver are aware and not blinded