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IRCT20090908002434N9 IRCT 2021-10-12 Shiraz University of Medical Sciences Comparison of the effect of Polyethylene Glycol (Single dose vs divided dose) in Treatment of Functional Constipation in Children Comparison of the effect of Polyethylene Glycol (Single dose vs divided dose) in Treatment of Functional Constipation in Children 2021-10-22 anticipated 80 Complete https://irct.ir/trial/58666 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done in a block method with a block size of 8. For each of the 10 possible cases for a block of eight, random numbers are selected between 1 and 10, and the treatment allocation list is specified according to each number. To execute the generated random sequence, the method of hiding encoded boxes or cans is used. In this method, the cans are numbered in a random sequence and inside the boxes, the desired intervention (drug) or a sheet on which the random allocation is written, is provided to the executor with the condition that the boxes are completely sealed. The researcher assigns patients to the standard intervention and treatment group based on the order of patients' entrance. Tool: In order to execute a random sequence on the study participants, block randomization with the block size of 8 will be created. How to make: Random selection of blocks and reading of letters from right to left will be done by the method of boxes numbered in random sequence. The cans are the same weight and shape and will be prepared by an independent researcher, Blinding description: In this double-blind study, polyethylene glycol syrup was used as a divided dose in the control group and a single dose in the experimental group. For this purpose, new patients referred to Imam Reza Clinic of Shiraz University of Medical Sciences after examination and diagnosis of constipation, The prescription sheet says the title of the medicine to treat constipation. The patient's initial information is recorded by staff who are also blind, and then the patient is referred to the clinic pharmacy for medication based on a table of block randomization with the block size of 8 . 3 Constipation. Intervention 1: Intervention group: polyethylene glycol was administered orally at a dose of 1 cc/kg body weight from a solution containing 40% without electrolytes (0.4 g/kg) on a single dose basis. Increasing the dose up to 2 cc/kg body weight (0.8 g/kg) daily was allowed by the caregiver for the children who did not improve after at least three days of treatment. It should be noted that the use of other laxatives was not allowed during the study period. In addition, if the patients did not defecate for more than three days, they were referred to a physician. A proper toilet training with regular stool sittings for 5-10 minutes was advised after each meal. Furthermore, the patients and their parents were asked to keep a stool diary during the 12 weeks of treatment, with weekly reports of the frequency of bowel movements, stool consistency measured through the Bristol Stool Form Scale , episodes of fecal incontinence, and presence of the associated gastrointestinal symptoms such as nausea, vomiting, flatulence, abdominal pain, painful defecation, and rectal bleeding. Intervention 2: Control group: 40 children use polyethylene glycol in divided dose as a treatment for constipation. Yes - There is a plan to make this available What will be shared: After the research and publication of the article, information about the main outcome and the interventions will be shared. When: At the end of the study since 2021 To whom: All physicians and researchers related to the field of pediatrics Conditions: For therapeutic and research use, information will be provided to all physicians and researchers Where to obtain: Shiraz Namazi Hospital, Pediatric's Department Office, Pediatric Gastroenterology Department How to obtain: By referring to Shiraz Namazi Hospital, Pediatric's Department Office, Pediatric Gastroenterology Department Comments:
public Naser Honar
Department of Pediatrics, Namazi Hospital, Namazi Sq
Shiraz Iran (Islamic Republic of) 7134874853 +98 71 3647 4298 Honarn@sums.ac.ir Shiraz University of Medical Sciences scientific Mohammad Hadi Imanieh
Department of Pediatrics, Namazi Hospital, Namazi Sq
Shiraz Iran (Islamic Republic of) 7134874853 +98 71 3647 4298 imaniehm@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) The children aged 4 to 15 years who had functional constipation on the base of Rome IV criteria. The patients which their information and follow ups were complete. 4 years 15 years Both K59.0 Constipation Treatment - Drugs Treatment - Drugs Intervention group: polyethylene glycol was administered orally at a dose of 1 cc/kg body weight from a solution containing 40% without electrolytes (0.4 g/kg) on a single dose basis. Increasing the dose up to 2 cc/kg body weight (0.8 g/kg) daily was allowed by the caregiver for the children who did not improve after at least three days of treatment. It should be noted that the use of other laxatives was not allowed during the study period. In addition, if the patients did not defecate for more than three days, they were referred to a physician. A proper toilet training with regular stool sittings for 5-10 minutes was advised after each meal. Furthermore, the patients and their parents were asked to keep a stool diary during the 12 weeks of treatment, with weekly reports of the frequency of bowel movements, stool consistency measured through the Bristol Stool Form Scale , episodes of fecal incontinence, and presence of the associated gastrointestinal symptoms such as nausea, vomiting, flatulence, abdominal pain, painful defecation, and rectal bleeding. Control group: 40 children use polyethylene glycol in divided dose as a treatment for constipation Defecation less than or equal to two times a week. Timepoint: Start treatment, one week later, three weeks later, six weeks later, twelve weeks later. Method of measurement: Questionnaire. History of stool retention. Timepoint: Start treatment, one week later, three weeks later, six weeks later, twelve weeks later. Method of measurement: Questionnaire. History of hard or painful defecation. Timepoint: Start treatment, one week later, three weeks later, six weeks later, twelve weeks later. Method of measurement: Questionnaire. History of thick stools that may block the toilet. Timepoint: Start treatment, one week later, three weeks later, six weeks later, twelve weeks later. Method of measurement: Questionnaire. Abdominal pain. Timepoint: Start treatment, one week later, three weeks later, six weeks later, twelve weeks later. Method of measurement: Questionnaire. Shiraz University of Medical Sciences Approved 2019-01-29 Ethics Committee of Shiraz University of Medical Sciences Zand Blvd Shiraz Fars Iran (Islamic Republic of)