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IRCT20181214041966N1 IRCT 2018-12-22 Ahvaz University of Medical Sciences Effect of Poly ethylene glycol and Lactoluse on abdominal pain in children Evaluation of Poly ethylene glycol and Lactulose effects on abdominal pain in children with fecal impaction and without ROME III criteria for constipation; (Occult constipation): a Randomized controlled study 2017-06-22 anticipated 52 Complete https://irct.ir/trial/35951 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method of randomization is simple and its unit is individual. The random sequence was carried out using random number table. Concealment was also carried out through similar drug containers, Blinding description: The present study has designed as double blind. The participants were unaware of the medicines, as their care givers were asked to give the patients the prepared medications; in form of solution or syrup in similar containers, making them unrecognizable from each other for patients. Meanwhile, the physicians who were assessing the patients abdominal pain had no knowledge of type of medication. 3 abdominal pain in pediatrics. Intervention 1: Intervention group: patients were treated with Poly ethylene glycol powder (Sepidaj Company, Iran) dissolved in water, at dose of 0.5 gr/kg every 12 h orally for at least two consecutive weeks. Chemically, Poly ethylene glycol is a water-soluble polymer with high molecular weight. Intervention 2: Control group: The patients were treated with Lactulose Syrup (Tolid daru Company, Iran), at dose of 0.5 cc/kg every 12 h orally, for at least two consecutive weeks. Chemically, Lactulose is a synthetic disaccharide composed of galactose and glucose. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Mehran Hakimzade
Abuzar hospital, Parastar Blv., Ahvaz
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3443 9916 hakimmehran@ajums.ac.ir Ahvaz University of Medical Sciences scientific Mehran Hakimzade
Abuzar hospital, Parastar Blv, Ahvaz
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3443 9916 hakimmehran@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) patients at the age of 4 to 18 years patients with abdominal pain more than 14 days patients with abdominal pain lacking ROME III criteria for constipation patients with fecal impaction in abdominal X ray 4 years 18 years Both Abdominal surgery Hematochezia Antibiotic consumption in the last 2 weeks Laxative consumption in the last 2 weeks R10.9 Unspecified abdominal pain Treatment - Drugs Treatment - Drugs Intervention group: patients were treated with Poly ethylene glycol powder (Sepidaj Company, Iran) dissolved in water, at dose of 0.5 gr/kg every 12 h orally for at least two consecutive weeks. Chemically, Poly ethylene glycol is a water-soluble polymer with high molecular weight. Control group: The patients were treated with Lactulose Syrup (Tolid daru Company, Iran), at dose of 0.5 cc/kg every 12 h orally, for at least two consecutive weeks. Chemically, Lactulose is a synthetic disaccharide composed of galactose and glucose. 56% of patients suffered from moderate abdominal pain. Timepoint: before intervention and 2, 3, 4, 5, 6, 8, 12 weeks after intervention. Method of measurement: pain score scale. Ahvaz University of Medical Sciences Approved 2018-12-15 Ethics committee of Ahvaz Jundishapor University of Medical Sciences Abuzar hospital, Parastar Blv, Ahvaz city Ahvaz Khouzestan Iran (Islamic Republic of)